Dulaglutide

FDA prescribing information

DailyMed, U.S. National Library of Medicine. TRULICITY (dulaglutide) injection, single-dose pen, prescribing information, label version effective 16 June 2026. Set ID 463050bd-2b1c-40f5-b3c3-0a04bb433309.

The label approves TRULICITY as an adjunct to diet and exercise to improve glycemic control in adults and children 10 years and older with type 2 diabetes, and to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke) in adults with type 2 diabetes and established cardiovascular disease or multiple cardiovascular risk factors. Weight management is not a labeled indication. There is a boxed warning for thyroid C-cell tumors in rats, and dulaglutide is contraindicated with a personal or family history of medullary thyroid carcinoma, MEN 2, or serious hypersensitivity to dulaglutide. Warnings cover acute pancreatitis, hypoglycemia with insulin or sulfonylureas, serious hypersensitivity, acute kidney injury from volume depletion, severe gastrointestinal reactions (not recommended in severe gastroparesis), diabetic retinopathy complications seen in the cardiovascular outcomes trial, gallbladder disease, and pulmonary aspiration during anesthesia or deep sedation. In pooled placebo-controlled trials, nausea occurred in 5.3% on placebo, 12.4% on 0.75 mg and 21.1% on 1.5 mg, and any gastrointestinal reaction in 21%, 32% and 41%. Dulaglutide is a fusion protein of two identical disulfide-linked chains, each a GLP-1 analog (90% homologous to human GLP-1(7-37), modified to resist DPP-4) joined by a peptide linker to a modified human IgG4 Fc heavy chain, made in Chinese hamster ovary cells, about 63 kDa. Mean absolute subcutaneous bioavailability was 65% at 0.75 mg and 47% at 1.5 mg, exposure rose roughly in proportion to dose, and the elimination half-life is about 5 days. It is presumed to be broken down by general protein catabolism. Age, sex, race, body weight, and renal or hepatic impairment had no clinically relevant effect on exposure. Weight changed -2.7 kg (0.75 mg) and -3.1 kg (1.5 mg) versus -1.5 kg on sitagliptin at 52 weeks; -2.9 kg on 1.5 mg versus -2.0 kg on placebo (difference -0.9 kg) as add-on to an SGLT2 inhibitor at 24 weeks; and -3.0, -3.8 and -4.6 kg on 1.5, 3 and 4.5 mg in the dose-ranging trial at 36 weeks from baselines near 95 kg.

Participants / model

Adults and children 10 years and older with type 2 diabetes; label PK participants; pooled placebo-controlled trial participants

Treatment

TRULICITY single-dose pen for subcutaneous injection, once weekly

Follow-up

Label version effective 16 June 2026; label trials of 24 to 52 weeks

Study design

FDA prescribing information

Funding

not stated in the source

Weight management is not a labeled indication. The label presents REWIND component results, including a hazard ratio of 0.76 for non-fatal stroke, as descriptive only, so they are not described here as significant. The retinopathy item is a warning with no incidence figure given here.

Regulatory record

U.S. Food and Drug Administration. Drugs@FDA application record for BLA 125469 (TRULICITY, Eli Lilly). Date read from the openFDA Drugs@FDA record on 10 October 2026.

FDA approved TRULICITY under BLA 125469 (Eli Lilly) on 18 September 2014.

Participants / model

Not a clinical population

Treatment

Biologics license application

Follow-up

Approved in 2014

Study design

FDA application record

Funding

not stated in the source

The record gives the approval date. Approvals outside the United States are not covered.

Randomized controlled trial

Dungan KM et al. Lancet. 2014;384(9951):1349-57. PMID 25018121.

At 26 weeks HbA1c fell 1.42% on dulaglutide versus 1.36% on liraglutide (difference -0.06%, 95% CI -0.19 to 0.07), meeting non-inferiority. Nausea occurred in 20% versus 18%, diarrhoea in 12% in each group and vomiting in 7% versus 8%. Adverse-event discontinuation was 6% in each group, and there was no severe hypoglycaemia.

Participants / model

599 metformin-treated adults with type 2 diabetes (HbA1c 7.0 to 10.0%, BMI 45 or lower), at 62 sites in nine countries

Treatment

Subcutaneous dulaglutide 1.5 mg weekly (299) versus liraglutide 1.8 mg daily (300)

Follow-up

26 weeks

Study design

Randomized open-label phase 3 non-inferiority trial (NCT01624259)

Funding

Funded by Lilly

Open-label, with an active comparator and no placebo arm.

Randomized controlled trial

Frias JP et al. Diabetes Care. 2021;44(3):765-773. PMID 33397768.

At 36 weeks, 4.5 mg lowered HbA1c more than 1.5 mg (treatment-regimen estimand -1.77% versus -1.54%, difference -0.24%) and weight more (-4.6 versus -3.0 kg, difference -1.6 kg). Nausea ran 13.4%, 15.6% and 16.4%, and vomiting 5.6%, 8.3% and 9.3%, across the three doses.

Participants / model

1,842 metformin-treated adults with type 2 diabetes (mean HbA1c 8.6%, BMI 34.2)

Treatment

Subcutaneous dulaglutide 1.5, 3.0 or 4.5 mg once weekly

Follow-up

52 weeks, with HbA1c and weight reported at 36 weeks

Study design

Randomized phase 3 dose comparison

Funding

not stated in the source

Lilly authors. The figures given are at 36 weeks.

Randomized controlled trial

Gerstein HC et al. Lancet. 2019;394(10193):121-130. PMID 31189511.

The primary composite (non-fatal myocardial infarction, non-fatal stroke, cardiovascular death) occurred in 594 (12.0%) versus 663 (13.4%), hazard ratio 0.88 (95% CI 0.79 to 0.99). All-cause death did not differ significantly (10.8% versus 12.0%, HR 0.90, 95% CI 0.80 to 1.01). Gastrointestinal adverse events were reported by 47.4% versus 34.1%.

Participants / model

9,901 people aged 50 or older with type 2 diabetes and prior cardiovascular disease or risk factors (mean age 66.2, median HbA1c 7.2%, 46.3% women), at 371 sites in 24 countries

Treatment

Subcutaneous dulaglutide 1.5 mg once weekly or placebo

Follow-up

Median 5.4 years

Study design

Randomized placebo-controlled cardiovascular outcomes trial (NCT01394952)

Funding

Funded by Lilly

The label gives REWIND component results, such as a hazard ratio of 0.76 for non-fatal stroke, as descriptive only.

FDA prescribing information

DailyMed, U.S. National Library of Medicine. TRULICITY (dulaglutide) injection, single-dose pen, prescribing information, label version effective 16 June 2026. Set ID 463050bd-2b1c-40f5-b3c3-0a04bb433309.

The label approves TRULICITY as an adjunct to diet and exercise to improve glycemic control in adults and children 10 years and older with type 2 diabetes, and to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke) in adults with type 2 diabetes and established cardiovascular disease or multiple cardiovascular risk factors. Weight management is not a labeled indication. There is a boxed warning for thyroid C-cell tumors in rats, and dulaglutide is contraindicated with a personal or family history of medullary thyroid carcinoma, MEN 2, or serious hypersensitivity to dulaglutide. Warnings cover acute pancreatitis, hypoglycemia with insulin or sulfonylureas, serious hypersensitivity, acute kidney injury from volume depletion, severe gastrointestinal reactions (not recommended in severe gastroparesis), diabetic retinopathy complications seen in the cardiovascular outcomes trial, gallbladder disease, and pulmonary aspiration during anesthesia or deep sedation. In pooled placebo-controlled trials, nausea occurred in 5.3% on placebo, 12.4% on 0.75 mg and 21.1% on 1.5 mg, and any gastrointestinal reaction in 21%, 32% and 41%. Dulaglutide is a fusion protein of two identical disulfide-linked chains, each a GLP-1 analog (90% homologous to human GLP-1(7-37), modified to resist DPP-4) joined by a peptide linker to a modified human IgG4 Fc heavy chain, made in Chinese hamster ovary cells, about 63 kDa. Mean absolute subcutaneous bioavailability was 65% at 0.75 mg and 47% at 1.5 mg, exposure rose roughly in proportion to dose, and the elimination half-life is about 5 days. It is presumed to be broken down by general protein catabolism. Age, sex, race, body weight, and renal or hepatic impairment had no clinically relevant effect on exposure. Weight changed -2.7 kg (0.75 mg) and -3.1 kg (1.5 mg) versus -1.5 kg on sitagliptin at 52 weeks; -2.9 kg on 1.5 mg versus -2.0 kg on placebo (difference -0.9 kg) as add-on to an SGLT2 inhibitor at 24 weeks; and -3.0, -3.8 and -4.6 kg on 1.5, 3 and 4.5 mg in the dose-ranging trial at 36 weeks from baselines near 95 kg.

Participants / model

Adults and children 10 years and older with type 2 diabetes; label PK participants; pooled placebo-controlled trial participants

Treatment

TRULICITY single-dose pen for subcutaneous injection, once weekly

Follow-up

Label version effective 16 June 2026; label trials of 24 to 52 weeks

Study design

FDA prescribing information

Funding

not stated in the source

Weight management is not a labeled indication. The label presents REWIND component results, including a hazard ratio of 0.76 for non-fatal stroke, as descriptive only, so they are not described here as significant. The retinopathy item is a warning with no incidence figure given here.

Randomized controlled trial

Pratley RE et al. Lancet Diabetes Endocrinol. 2018;6(4):275-286. PMID 29397376.

Semaglutide beat dulaglutide at matched dose levels. At 40 weeks HbA1c fell 1.8 points on semaglutide 1.0 mg versus 1.4 on dulaglutide 1.5 mg, and weight fell 6.5 kg versus 3.0 kg (difference -3.55 kg, 95% CI -4.32 to -2.78). Gastrointestinal disorders occurred in 44% on semaglutide 1.0 mg and 48% on dulaglutide 1.5 mg.

Participants / model

1,201 adults with type 2 diabetes on metformin (HbA1c 7.0 to 10.5%)

Treatment

Subcutaneous semaglutide 0.5 or 1.0 mg versus dulaglutide 0.75 or 1.5 mg, once weekly

Follow-up

40 weeks

Study design

Randomized open-label phase 3b trial (NCT02648204)

Funding

not stated in the source

Dulaglutide was the comparator, so this is the head-to-head weight comparison, not a dulaglutide placebo trial.

Randomized controlled trial

Nicholls SJ et al. N Engl J Med. 2025;393(24):2409-2420. PMID 41406444.

The composite of cardiovascular death, myocardial infarction or stroke occurred in 12.2% on tirzepatide and 13.1% on dulaglutide (HR 0.92, 95.3% CI 0.83 to 1.01), non-inferior but not superior. More gastrointestinal adverse events occurred with tirzepatide.

Participants / model

13,165 adults with type 2 diabetes and atherosclerotic cardiovascular disease (modified intention-to-treat population)

Treatment

Subcutaneous tirzepatide up to 15 mg versus dulaglutide 1.5 mg, once weekly

Follow-up

not stated in the source

Study design

Randomized cardiovascular outcomes trial with dulaglutide as the active comparator

Funding

not stated in the source

Dulaglutide was the comparator, so this page uses it as context, not as a dulaglutide efficacy result.

Randomized controlled trial

Arslanian SA et al. N Engl J Med. 2022;387(5):433-443. PMID 35658022.

HbA1c rose 0.6 points on placebo and fell 0.6 and 0.9 points on dulaglutide, and 51% versus 14% reached HbA1c under 7.0%. BMI change did not differ between groups. Gastrointestinal events were more common on dulaglutide.

Participants / model

154 youths aged 10 to under 18 with type 2 diabetes and BMI above the 85th percentile

Treatment

Subcutaneous placebo, dulaglutide 0.75 mg or dulaglutide 1.5 mg, once weekly

Follow-up

26 weeks

Study design

Randomized placebo-controlled trial

Funding

not stated in the source

The 51% versus 14% figure is dulaglutide against placebo, as given in the source summary.

FDA prescribing information

DailyMed, U.S. National Library of Medicine. TRULICITY (dulaglutide) injection, single-dose pen, prescribing information, label version effective 16 June 2026. Set ID 463050bd-2b1c-40f5-b3c3-0a04bb433309.

The label approves TRULICITY as an adjunct to diet and exercise to improve glycemic control in adults and children 10 years and older with type 2 diabetes, and to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke) in adults with type 2 diabetes and established cardiovascular disease or multiple cardiovascular risk factors. Weight management is not a labeled indication. There is a boxed warning for thyroid C-cell tumors in rats, and dulaglutide is contraindicated with a personal or family history of medullary thyroid carcinoma, MEN 2, or serious hypersensitivity to dulaglutide. Warnings cover acute pancreatitis, hypoglycemia with insulin or sulfonylureas, serious hypersensitivity, acute kidney injury from volume depletion, severe gastrointestinal reactions (not recommended in severe gastroparesis), diabetic retinopathy complications seen in the cardiovascular outcomes trial, gallbladder disease, and pulmonary aspiration during anesthesia or deep sedation. In pooled placebo-controlled trials, nausea occurred in 5.3% on placebo, 12.4% on 0.75 mg and 21.1% on 1.5 mg, and any gastrointestinal reaction in 21%, 32% and 41%. Dulaglutide is a fusion protein of two identical disulfide-linked chains, each a GLP-1 analog (90% homologous to human GLP-1(7-37), modified to resist DPP-4) joined by a peptide linker to a modified human IgG4 Fc heavy chain, made in Chinese hamster ovary cells, about 63 kDa. Mean absolute subcutaneous bioavailability was 65% at 0.75 mg and 47% at 1.5 mg, exposure rose roughly in proportion to dose, and the elimination half-life is about 5 days. It is presumed to be broken down by general protein catabolism. Age, sex, race, body weight, and renal or hepatic impairment had no clinically relevant effect on exposure. Weight changed -2.7 kg (0.75 mg) and -3.1 kg (1.5 mg) versus -1.5 kg on sitagliptin at 52 weeks; -2.9 kg on 1.5 mg versus -2.0 kg on placebo (difference -0.9 kg) as add-on to an SGLT2 inhibitor at 24 weeks; and -3.0, -3.8 and -4.6 kg on 1.5, 3 and 4.5 mg in the dose-ranging trial at 36 weeks from baselines near 95 kg.

Participants / model

Adults and children 10 years and older with type 2 diabetes; label PK participants; pooled placebo-controlled trial participants

Treatment

TRULICITY single-dose pen for subcutaneous injection, once weekly

Follow-up

Label version effective 16 June 2026; label trials of 24 to 52 weeks

Study design

FDA prescribing information

Funding

not stated in the source

Weight management is not a labeled indication. The label presents REWIND component results, including a hazard ratio of 0.76 for non-fatal stroke, as descriptive only, so they are not described here as significant. The retinopathy item is a warning with no incidence figure given here.

FDA prescribing information

DailyMed, U.S. National Library of Medicine. TRULICITY (dulaglutide) injection, single-dose pen, prescribing information, label version effective 16 June 2026. Set ID 463050bd-2b1c-40f5-b3c3-0a04bb433309.

The label approves TRULICITY as an adjunct to diet and exercise to improve glycemic control in adults and children 10 years and older with type 2 diabetes, and to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke) in adults with type 2 diabetes and established cardiovascular disease or multiple cardiovascular risk factors. Weight management is not a labeled indication. There is a boxed warning for thyroid C-cell tumors in rats, and dulaglutide is contraindicated with a personal or family history of medullary thyroid carcinoma, MEN 2, or serious hypersensitivity to dulaglutide. Warnings cover acute pancreatitis, hypoglycemia with insulin or sulfonylureas, serious hypersensitivity, acute kidney injury from volume depletion, severe gastrointestinal reactions (not recommended in severe gastroparesis), diabetic retinopathy complications seen in the cardiovascular outcomes trial, gallbladder disease, and pulmonary aspiration during anesthesia or deep sedation. In pooled placebo-controlled trials, nausea occurred in 5.3% on placebo, 12.4% on 0.75 mg and 21.1% on 1.5 mg, and any gastrointestinal reaction in 21%, 32% and 41%. Dulaglutide is a fusion protein of two identical disulfide-linked chains, each a GLP-1 analog (90% homologous to human GLP-1(7-37), modified to resist DPP-4) joined by a peptide linker to a modified human IgG4 Fc heavy chain, made in Chinese hamster ovary cells, about 63 kDa. Mean absolute subcutaneous bioavailability was 65% at 0.75 mg and 47% at 1.5 mg, exposure rose roughly in proportion to dose, and the elimination half-life is about 5 days. It is presumed to be broken down by general protein catabolism. Age, sex, race, body weight, and renal or hepatic impairment had no clinically relevant effect on exposure. Weight changed -2.7 kg (0.75 mg) and -3.1 kg (1.5 mg) versus -1.5 kg on sitagliptin at 52 weeks; -2.9 kg on 1.5 mg versus -2.0 kg on placebo (difference -0.9 kg) as add-on to an SGLT2 inhibitor at 24 weeks; and -3.0, -3.8 and -4.6 kg on 1.5, 3 and 4.5 mg in the dose-ranging trial at 36 weeks from baselines near 95 kg.

Participants / model

Adults and children 10 years and older with type 2 diabetes; label PK participants; pooled placebo-controlled trial participants

Treatment

TRULICITY single-dose pen for subcutaneous injection, once weekly

Follow-up

Label version effective 16 June 2026; label trials of 24 to 52 weeks

Study design

FDA prescribing information

Funding

not stated in the source

Weight management is not a labeled indication. The label presents REWIND component results, including a hazard ratio of 0.76 for non-fatal stroke, as descriptive only, so they are not described here as significant. The retinopathy item is a warning with no incidence figure given here.

Randomized controlled trial

Frias JP et al. Diabetes Care. 2021;44(3):765-773. PMID 33397768.

At 36 weeks, 4.5 mg lowered HbA1c more than 1.5 mg (treatment-regimen estimand -1.77% versus -1.54%, difference -0.24%) and weight more (-4.6 versus -3.0 kg, difference -1.6 kg). Nausea ran 13.4%, 15.6% and 16.4%, and vomiting 5.6%, 8.3% and 9.3%, across the three doses.

Participants / model

1,842 metformin-treated adults with type 2 diabetes (mean HbA1c 8.6%, BMI 34.2)

Treatment

Subcutaneous dulaglutide 1.5, 3.0 or 4.5 mg once weekly

Follow-up

52 weeks, with HbA1c and weight reported at 36 weeks

Study design

Randomized phase 3 dose comparison

Funding

not stated in the source

Lilly authors. The figures given are at 36 weeks.

Randomized controlled trial

Pratley RE et al. Lancet Diabetes Endocrinol. 2018;6(4):275-286. PMID 29397376.

Semaglutide beat dulaglutide at matched dose levels. At 40 weeks HbA1c fell 1.8 points on semaglutide 1.0 mg versus 1.4 on dulaglutide 1.5 mg, and weight fell 6.5 kg versus 3.0 kg (difference -3.55 kg, 95% CI -4.32 to -2.78). Gastrointestinal disorders occurred in 44% on semaglutide 1.0 mg and 48% on dulaglutide 1.5 mg.

Participants / model

1,201 adults with type 2 diabetes on metformin (HbA1c 7.0 to 10.5%)

Treatment

Subcutaneous semaglutide 0.5 or 1.0 mg versus dulaglutide 0.75 or 1.5 mg, once weekly

Follow-up

40 weeks

Study design

Randomized open-label phase 3b trial (NCT02648204)

Funding

not stated in the source

Dulaglutide was the comparator, so this is the head-to-head weight comparison, not a dulaglutide placebo trial.

PubMed search record

Zhang Y et al. Nutrients. 2023;15(3). PMID 36771262.

The search returned 2 records: a smoking-cessation blood pressure analysis and one open-label trial of 68 overweight or obese women with polycystic ovary syndrome, in which dulaglutide plus a calorie-restricted diet reached 7% weight loss faster than diet alone but did not reduce visceral fat area more (difference -0.97 cm2, 95% CI -14.36 to 12.42). No obesity-indication trial of dulaglutide appeared.

Participants / model

Records reviewed; 68 women with polycystic ovary syndrome in the one weight trial

Treatment

Subcutaneous dulaglutide with a calorie-restricted diet

Follow-up

Search run on 10 October 2026

Study design

Literature search plus one small open-label randomized trial

Funding

not stated in the source

A search result shows what PubMed returned on that date. It is not proof that no unindexed study exists.

FDA prescribing information

DailyMed, U.S. National Library of Medicine. TRULICITY (dulaglutide) injection, single-dose pen, prescribing information, label version effective 16 June 2026. Set ID 463050bd-2b1c-40f5-b3c3-0a04bb433309.

The label approves TRULICITY as an adjunct to diet and exercise to improve glycemic control in adults and children 10 years and older with type 2 diabetes, and to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke) in adults with type 2 diabetes and established cardiovascular disease or multiple cardiovascular risk factors. Weight management is not a labeled indication. There is a boxed warning for thyroid C-cell tumors in rats, and dulaglutide is contraindicated with a personal or family history of medullary thyroid carcinoma, MEN 2, or serious hypersensitivity to dulaglutide. Warnings cover acute pancreatitis, hypoglycemia with insulin or sulfonylureas, serious hypersensitivity, acute kidney injury from volume depletion, severe gastrointestinal reactions (not recommended in severe gastroparesis), diabetic retinopathy complications seen in the cardiovascular outcomes trial, gallbladder disease, and pulmonary aspiration during anesthesia or deep sedation. In pooled placebo-controlled trials, nausea occurred in 5.3% on placebo, 12.4% on 0.75 mg and 21.1% on 1.5 mg, and any gastrointestinal reaction in 21%, 32% and 41%. Dulaglutide is a fusion protein of two identical disulfide-linked chains, each a GLP-1 analog (90% homologous to human GLP-1(7-37), modified to resist DPP-4) joined by a peptide linker to a modified human IgG4 Fc heavy chain, made in Chinese hamster ovary cells, about 63 kDa. Mean absolute subcutaneous bioavailability was 65% at 0.75 mg and 47% at 1.5 mg, exposure rose roughly in proportion to dose, and the elimination half-life is about 5 days. It is presumed to be broken down by general protein catabolism. Age, sex, race, body weight, and renal or hepatic impairment had no clinically relevant effect on exposure. Weight changed -2.7 kg (0.75 mg) and -3.1 kg (1.5 mg) versus -1.5 kg on sitagliptin at 52 weeks; -2.9 kg on 1.5 mg versus -2.0 kg on placebo (difference -0.9 kg) as add-on to an SGLT2 inhibitor at 24 weeks; and -3.0, -3.8 and -4.6 kg on 1.5, 3 and 4.5 mg in the dose-ranging trial at 36 weeks from baselines near 95 kg.

Participants / model

Adults and children 10 years and older with type 2 diabetes; label PK participants; pooled placebo-controlled trial participants

Treatment

TRULICITY single-dose pen for subcutaneous injection, once weekly

Follow-up

Label version effective 16 June 2026; label trials of 24 to 52 weeks

Study design

FDA prescribing information

Funding

not stated in the source

Weight management is not a labeled indication. The label presents REWIND component results, including a hazard ratio of 0.76 for non-fatal stroke, as descriptive only, so they are not described here as significant. The retinopathy item is a warning with no incidence figure given here.

Randomized controlled trial

Gerstein HC et al. Lancet. 2019;394(10193):121-130. PMID 31189511.

The primary composite (non-fatal myocardial infarction, non-fatal stroke, cardiovascular death) occurred in 594 (12.0%) versus 663 (13.4%), hazard ratio 0.88 (95% CI 0.79 to 0.99). All-cause death did not differ significantly (10.8% versus 12.0%, HR 0.90, 95% CI 0.80 to 1.01). Gastrointestinal adverse events were reported by 47.4% versus 34.1%.

Participants / model

9,901 people aged 50 or older with type 2 diabetes and prior cardiovascular disease or risk factors (mean age 66.2, median HbA1c 7.2%, 46.3% women), at 371 sites in 24 countries

Treatment

Subcutaneous dulaglutide 1.5 mg once weekly or placebo

Follow-up

Median 5.4 years

Study design

Randomized placebo-controlled cardiovascular outcomes trial (NCT01394952)

Funding

Funded by Lilly

The label gives REWIND component results, such as a hazard ratio of 0.76 for non-fatal stroke, as descriptive only.

Randomized controlled trial

Dungan KM et al. Lancet. 2014;384(9951):1349-57. PMID 25018121.

At 26 weeks HbA1c fell 1.42% on dulaglutide versus 1.36% on liraglutide (difference -0.06%, 95% CI -0.19 to 0.07), meeting non-inferiority. Nausea occurred in 20% versus 18%, diarrhoea in 12% in each group and vomiting in 7% versus 8%. Adverse-event discontinuation was 6% in each group, and there was no severe hypoglycaemia.

Participants / model

599 metformin-treated adults with type 2 diabetes (HbA1c 7.0 to 10.0%, BMI 45 or lower), at 62 sites in nine countries

Treatment

Subcutaneous dulaglutide 1.5 mg weekly (299) versus liraglutide 1.8 mg daily (300)

Follow-up

26 weeks

Study design

Randomized open-label phase 3 non-inferiority trial (NCT01624259)

Funding

Funded by Lilly

Open-label, with an active comparator and no placebo arm.

Randomized controlled trial

Pratley RE et al. Lancet Diabetes Endocrinol. 2018;6(4):275-286. PMID 29397376.

Semaglutide beat dulaglutide at matched dose levels. At 40 weeks HbA1c fell 1.8 points on semaglutide 1.0 mg versus 1.4 on dulaglutide 1.5 mg, and weight fell 6.5 kg versus 3.0 kg (difference -3.55 kg, 95% CI -4.32 to -2.78). Gastrointestinal disorders occurred in 44% on semaglutide 1.0 mg and 48% on dulaglutide 1.5 mg.

Participants / model

1,201 adults with type 2 diabetes on metformin (HbA1c 7.0 to 10.5%)

Treatment

Subcutaneous semaglutide 0.5 or 1.0 mg versus dulaglutide 0.75 or 1.5 mg, once weekly

Follow-up

40 weeks

Study design

Randomized open-label phase 3b trial (NCT02648204)

Funding

not stated in the source

Dulaglutide was the comparator, so this is the head-to-head weight comparison, not a dulaglutide placebo trial.

PubMed search record

Zhang Y et al. Nutrients. 2023;15(3). PMID 36771262.

The search returned 2 records: a smoking-cessation blood pressure analysis and one open-label trial of 68 overweight or obese women with polycystic ovary syndrome, in which dulaglutide plus a calorie-restricted diet reached 7% weight loss faster than diet alone but did not reduce visceral fat area more (difference -0.97 cm2, 95% CI -14.36 to 12.42). No obesity-indication trial of dulaglutide appeared.

Participants / model

Records reviewed; 68 women with polycystic ovary syndrome in the one weight trial

Treatment

Subcutaneous dulaglutide with a calorie-restricted diet

Follow-up

Search run on 10 October 2026

Study design

Literature search plus one small open-label randomized trial

Funding

not stated in the source

A search result shows what PubMed returned on that date. It is not proof that no unindexed study exists.

FDA prescribing information

DailyMed, U.S. National Library of Medicine. TRULICITY (dulaglutide) injection, single-dose pen, prescribing information, label version effective 16 June 2026. Set ID 463050bd-2b1c-40f5-b3c3-0a04bb433309.

The label approves TRULICITY as an adjunct to diet and exercise to improve glycemic control in adults and children 10 years and older with type 2 diabetes, and to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke) in adults with type 2 diabetes and established cardiovascular disease or multiple cardiovascular risk factors. Weight management is not a labeled indication. There is a boxed warning for thyroid C-cell tumors in rats, and dulaglutide is contraindicated with a personal or family history of medullary thyroid carcinoma, MEN 2, or serious hypersensitivity to dulaglutide. Warnings cover acute pancreatitis, hypoglycemia with insulin or sulfonylureas, serious hypersensitivity, acute kidney injury from volume depletion, severe gastrointestinal reactions (not recommended in severe gastroparesis), diabetic retinopathy complications seen in the cardiovascular outcomes trial, gallbladder disease, and pulmonary aspiration during anesthesia or deep sedation. In pooled placebo-controlled trials, nausea occurred in 5.3% on placebo, 12.4% on 0.75 mg and 21.1% on 1.5 mg, and any gastrointestinal reaction in 21%, 32% and 41%. Dulaglutide is a fusion protein of two identical disulfide-linked chains, each a GLP-1 analog (90% homologous to human GLP-1(7-37), modified to resist DPP-4) joined by a peptide linker to a modified human IgG4 Fc heavy chain, made in Chinese hamster ovary cells, about 63 kDa. Mean absolute subcutaneous bioavailability was 65% at 0.75 mg and 47% at 1.5 mg, exposure rose roughly in proportion to dose, and the elimination half-life is about 5 days. It is presumed to be broken down by general protein catabolism. Age, sex, race, body weight, and renal or hepatic impairment had no clinically relevant effect on exposure. Weight changed -2.7 kg (0.75 mg) and -3.1 kg (1.5 mg) versus -1.5 kg on sitagliptin at 52 weeks; -2.9 kg on 1.5 mg versus -2.0 kg on placebo (difference -0.9 kg) as add-on to an SGLT2 inhibitor at 24 weeks; and -3.0, -3.8 and -4.6 kg on 1.5, 3 and 4.5 mg in the dose-ranging trial at 36 weeks from baselines near 95 kg.

Participants / model

Adults and children 10 years and older with type 2 diabetes; label PK participants; pooled placebo-controlled trial participants

Treatment

TRULICITY single-dose pen for subcutaneous injection, once weekly

Follow-up

Label version effective 16 June 2026; label trials of 24 to 52 weeks

Study design

FDA prescribing information

Funding

not stated in the source

Weight management is not a labeled indication. The label presents REWIND component results, including a hazard ratio of 0.76 for non-fatal stroke, as descriptive only, so they are not described here as significant. The retinopathy item is a warning with no incidence figure given here.

FDA prescribing information

DailyMed, U.S. National Library of Medicine. TRULICITY (dulaglutide) injection, single-dose pen, prescribing information, label version effective 16 June 2026. Set ID 463050bd-2b1c-40f5-b3c3-0a04bb433309.

The label approves TRULICITY as an adjunct to diet and exercise to improve glycemic control in adults and children 10 years and older with type 2 diabetes, and to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke) in adults with type 2 diabetes and established cardiovascular disease or multiple cardiovascular risk factors. Weight management is not a labeled indication. There is a boxed warning for thyroid C-cell tumors in rats, and dulaglutide is contraindicated with a personal or family history of medullary thyroid carcinoma, MEN 2, or serious hypersensitivity to dulaglutide. Warnings cover acute pancreatitis, hypoglycemia with insulin or sulfonylureas, serious hypersensitivity, acute kidney injury from volume depletion, severe gastrointestinal reactions (not recommended in severe gastroparesis), diabetic retinopathy complications seen in the cardiovascular outcomes trial, gallbladder disease, and pulmonary aspiration during anesthesia or deep sedation. In pooled placebo-controlled trials, nausea occurred in 5.3% on placebo, 12.4% on 0.75 mg and 21.1% on 1.5 mg, and any gastrointestinal reaction in 21%, 32% and 41%. Dulaglutide is a fusion protein of two identical disulfide-linked chains, each a GLP-1 analog (90% homologous to human GLP-1(7-37), modified to resist DPP-4) joined by a peptide linker to a modified human IgG4 Fc heavy chain, made in Chinese hamster ovary cells, about 63 kDa. Mean absolute subcutaneous bioavailability was 65% at 0.75 mg and 47% at 1.5 mg, exposure rose roughly in proportion to dose, and the elimination half-life is about 5 days. It is presumed to be broken down by general protein catabolism. Age, sex, race, body weight, and renal or hepatic impairment had no clinically relevant effect on exposure. Weight changed -2.7 kg (0.75 mg) and -3.1 kg (1.5 mg) versus -1.5 kg on sitagliptin at 52 weeks; -2.9 kg on 1.5 mg versus -2.0 kg on placebo (difference -0.9 kg) as add-on to an SGLT2 inhibitor at 24 weeks; and -3.0, -3.8 and -4.6 kg on 1.5, 3 and 4.5 mg in the dose-ranging trial at 36 weeks from baselines near 95 kg.

Participants / model

Adults and children 10 years and older with type 2 diabetes; label PK participants; pooled placebo-controlled trial participants

Treatment

TRULICITY single-dose pen for subcutaneous injection, once weekly

Follow-up

Label version effective 16 June 2026; label trials of 24 to 52 weeks

Study design

FDA prescribing information

Funding

not stated in the source

Weight management is not a labeled indication. The label presents REWIND component results, including a hazard ratio of 0.76 for non-fatal stroke, as descriptive only, so they are not described here as significant. The retinopathy item is a warning with no incidence figure given here.

Randomized controlled trial

Dungan KM et al. Lancet. 2014;384(9951):1349-57. PMID 25018121.

At 26 weeks HbA1c fell 1.42% on dulaglutide versus 1.36% on liraglutide (difference -0.06%, 95% CI -0.19 to 0.07), meeting non-inferiority. Nausea occurred in 20% versus 18%, diarrhoea in 12% in each group and vomiting in 7% versus 8%. Adverse-event discontinuation was 6% in each group, and there was no severe hypoglycaemia.

Participants / model

599 metformin-treated adults with type 2 diabetes (HbA1c 7.0 to 10.0%, BMI 45 or lower), at 62 sites in nine countries

Treatment

Subcutaneous dulaglutide 1.5 mg weekly (299) versus liraglutide 1.8 mg daily (300)

Follow-up

26 weeks

Study design

Randomized open-label phase 3 non-inferiority trial (NCT01624259)

Funding

Funded by Lilly

Open-label, with an active comparator and no placebo arm.

Randomized controlled trial

Frias JP et al. Diabetes Care. 2021;44(3):765-773. PMID 33397768.

At 36 weeks, 4.5 mg lowered HbA1c more than 1.5 mg (treatment-regimen estimand -1.77% versus -1.54%, difference -0.24%) and weight more (-4.6 versus -3.0 kg, difference -1.6 kg). Nausea ran 13.4%, 15.6% and 16.4%, and vomiting 5.6%, 8.3% and 9.3%, across the three doses.

Participants / model

1,842 metformin-treated adults with type 2 diabetes (mean HbA1c 8.6%, BMI 34.2)

Treatment

Subcutaneous dulaglutide 1.5, 3.0 or 4.5 mg once weekly

Follow-up

52 weeks, with HbA1c and weight reported at 36 weeks

Study design

Randomized phase 3 dose comparison

Funding

not stated in the source

Lilly authors. The figures given are at 36 weeks.

Randomized controlled trial

Gerstein HC et al. Lancet. 2019;394(10193):121-130. PMID 31189511.

The primary composite (non-fatal myocardial infarction, non-fatal stroke, cardiovascular death) occurred in 594 (12.0%) versus 663 (13.4%), hazard ratio 0.88 (95% CI 0.79 to 0.99). All-cause death did not differ significantly (10.8% versus 12.0%, HR 0.90, 95% CI 0.80 to 1.01). Gastrointestinal adverse events were reported by 47.4% versus 34.1%.

Participants / model

9,901 people aged 50 or older with type 2 diabetes and prior cardiovascular disease or risk factors (mean age 66.2, median HbA1c 7.2%, 46.3% women), at 371 sites in 24 countries

Treatment

Subcutaneous dulaglutide 1.5 mg once weekly or placebo

Follow-up

Median 5.4 years

Study design

Randomized placebo-controlled cardiovascular outcomes trial (NCT01394952)

Funding

Funded by Lilly

The label gives REWIND component results, such as a hazard ratio of 0.76 for non-fatal stroke, as descriptive only.

Randomized controlled trial

Arslanian SA et al. N Engl J Med. 2022;387(5):433-443. PMID 35658022.

HbA1c rose 0.6 points on placebo and fell 0.6 and 0.9 points on dulaglutide, and 51% versus 14% reached HbA1c under 7.0%. BMI change did not differ between groups. Gastrointestinal events were more common on dulaglutide.

Participants / model

154 youths aged 10 to under 18 with type 2 diabetes and BMI above the 85th percentile

Treatment

Subcutaneous placebo, dulaglutide 0.75 mg or dulaglutide 1.5 mg, once weekly

Follow-up

26 weeks

Study design

Randomized placebo-controlled trial

Funding

not stated in the source

The 51% versus 14% figure is dulaglutide against placebo, as given in the source summary.

FDA prescribing information

DailyMed, U.S. National Library of Medicine. TRULICITY (dulaglutide) injection, single-dose pen, prescribing information, label version effective 16 June 2026. Set ID 463050bd-2b1c-40f5-b3c3-0a04bb433309.

The label approves TRULICITY as an adjunct to diet and exercise to improve glycemic control in adults and children 10 years and older with type 2 diabetes, and to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke) in adults with type 2 diabetes and established cardiovascular disease or multiple cardiovascular risk factors. Weight management is not a labeled indication. There is a boxed warning for thyroid C-cell tumors in rats, and dulaglutide is contraindicated with a personal or family history of medullary thyroid carcinoma, MEN 2, or serious hypersensitivity to dulaglutide. Warnings cover acute pancreatitis, hypoglycemia with insulin or sulfonylureas, serious hypersensitivity, acute kidney injury from volume depletion, severe gastrointestinal reactions (not recommended in severe gastroparesis), diabetic retinopathy complications seen in the cardiovascular outcomes trial, gallbladder disease, and pulmonary aspiration during anesthesia or deep sedation. In pooled placebo-controlled trials, nausea occurred in 5.3% on placebo, 12.4% on 0.75 mg and 21.1% on 1.5 mg, and any gastrointestinal reaction in 21%, 32% and 41%. Dulaglutide is a fusion protein of two identical disulfide-linked chains, each a GLP-1 analog (90% homologous to human GLP-1(7-37), modified to resist DPP-4) joined by a peptide linker to a modified human IgG4 Fc heavy chain, made in Chinese hamster ovary cells, about 63 kDa. Mean absolute subcutaneous bioavailability was 65% at 0.75 mg and 47% at 1.5 mg, exposure rose roughly in proportion to dose, and the elimination half-life is about 5 days. It is presumed to be broken down by general protein catabolism. Age, sex, race, body weight, and renal or hepatic impairment had no clinically relevant effect on exposure. Weight changed -2.7 kg (0.75 mg) and -3.1 kg (1.5 mg) versus -1.5 kg on sitagliptin at 52 weeks; -2.9 kg on 1.5 mg versus -2.0 kg on placebo (difference -0.9 kg) as add-on to an SGLT2 inhibitor at 24 weeks; and -3.0, -3.8 and -4.6 kg on 1.5, 3 and 4.5 mg in the dose-ranging trial at 36 weeks from baselines near 95 kg.

Participants / model

Adults and children 10 years and older with type 2 diabetes; label PK participants; pooled placebo-controlled trial participants

Treatment

TRULICITY single-dose pen for subcutaneous injection, once weekly

Follow-up

Label version effective 16 June 2026; label trials of 24 to 52 weeks

Study design

FDA prescribing information

Funding

not stated in the source

Weight management is not a labeled indication. The label presents REWIND component results, including a hazard ratio of 0.76 for non-fatal stroke, as descriptive only, so they are not described here as significant. The retinopathy item is a warning with no incidence figure given here.

Regulatory record

U.S. Food and Drug Administration. Drugs@FDA application record for BLA 125469 (TRULICITY, Eli Lilly). Date read from the openFDA Drugs@FDA record on 10 October 2026.

FDA approved TRULICITY under BLA 125469 (Eli Lilly) on 18 September 2014.

Participants / model

Not a clinical population

Treatment

Biologics license application

Follow-up

Approved in 2014

Study design

FDA application record

Funding

not stated in the source

The record gives the approval date. Approvals outside the United States are not covered.

Randomized controlled trial

Gerstein HC et al. Lancet. 2019;394(10193):121-130. PMID 31189511.

The primary composite (non-fatal myocardial infarction, non-fatal stroke, cardiovascular death) occurred in 594 (12.0%) versus 663 (13.4%), hazard ratio 0.88 (95% CI 0.79 to 0.99). All-cause death did not differ significantly (10.8% versus 12.0%, HR 0.90, 95% CI 0.80 to 1.01). Gastrointestinal adverse events were reported by 47.4% versus 34.1%.

Participants / model

9,901 people aged 50 or older with type 2 diabetes and prior cardiovascular disease or risk factors (mean age 66.2, median HbA1c 7.2%, 46.3% women), at 371 sites in 24 countries

Treatment

Subcutaneous dulaglutide 1.5 mg once weekly or placebo

Follow-up

Median 5.4 years

Study design

Randomized placebo-controlled cardiovascular outcomes trial (NCT01394952)

Funding

Funded by Lilly

The label gives REWIND component results, such as a hazard ratio of 0.76 for non-fatal stroke, as descriptive only.

Randomized controlled trial

Dungan KM et al. Lancet. 2014;384(9951):1349-57. PMID 25018121.

At 26 weeks HbA1c fell 1.42% on dulaglutide versus 1.36% on liraglutide (difference -0.06%, 95% CI -0.19 to 0.07), meeting non-inferiority. Nausea occurred in 20% versus 18%, diarrhoea in 12% in each group and vomiting in 7% versus 8%. Adverse-event discontinuation was 6% in each group, and there was no severe hypoglycaemia.

Participants / model

599 metformin-treated adults with type 2 diabetes (HbA1c 7.0 to 10.0%, BMI 45 or lower), at 62 sites in nine countries

Treatment

Subcutaneous dulaglutide 1.5 mg weekly (299) versus liraglutide 1.8 mg daily (300)

Follow-up

26 weeks

Study design

Randomized open-label phase 3 non-inferiority trial (NCT01624259)

Funding

Funded by Lilly

Open-label, with an active comparator and no placebo arm.

PubMed search record

Zhang Y et al. Nutrients. 2023;15(3). PMID 36771262.

The search returned 2 records: a smoking-cessation blood pressure analysis and one open-label trial of 68 overweight or obese women with polycystic ovary syndrome, in which dulaglutide plus a calorie-restricted diet reached 7% weight loss faster than diet alone but did not reduce visceral fat area more (difference -0.97 cm2, 95% CI -14.36 to 12.42). No obesity-indication trial of dulaglutide appeared.

Participants / model

Records reviewed; 68 women with polycystic ovary syndrome in the one weight trial

Treatment

Subcutaneous dulaglutide with a calorie-restricted diet

Follow-up

Search run on 10 October 2026

Study design

Literature search plus one small open-label randomized trial

Funding

not stated in the source

A search result shows what PubMed returned on that date. It is not proof that no unindexed study exists.

FDA prescribing information

DailyMed, U.S. National Library of Medicine. TRULICITY (dulaglutide) injection, single-dose pen, prescribing information, label version effective 16 June 2026. Set ID 463050bd-2b1c-40f5-b3c3-0a04bb433309.

The label approves TRULICITY as an adjunct to diet and exercise to improve glycemic control in adults and children 10 years and older with type 2 diabetes, and to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke) in adults with type 2 diabetes and established cardiovascular disease or multiple cardiovascular risk factors. Weight management is not a labeled indication. There is a boxed warning for thyroid C-cell tumors in rats, and dulaglutide is contraindicated with a personal or family history of medullary thyroid carcinoma, MEN 2, or serious hypersensitivity to dulaglutide. Warnings cover acute pancreatitis, hypoglycemia with insulin or sulfonylureas, serious hypersensitivity, acute kidney injury from volume depletion, severe gastrointestinal reactions (not recommended in severe gastroparesis), diabetic retinopathy complications seen in the cardiovascular outcomes trial, gallbladder disease, and pulmonary aspiration during anesthesia or deep sedation. In pooled placebo-controlled trials, nausea occurred in 5.3% on placebo, 12.4% on 0.75 mg and 21.1% on 1.5 mg, and any gastrointestinal reaction in 21%, 32% and 41%. Dulaglutide is a fusion protein of two identical disulfide-linked chains, each a GLP-1 analog (90% homologous to human GLP-1(7-37), modified to resist DPP-4) joined by a peptide linker to a modified human IgG4 Fc heavy chain, made in Chinese hamster ovary cells, about 63 kDa. Mean absolute subcutaneous bioavailability was 65% at 0.75 mg and 47% at 1.5 mg, exposure rose roughly in proportion to dose, and the elimination half-life is about 5 days. It is presumed to be broken down by general protein catabolism. Age, sex, race, body weight, and renal or hepatic impairment had no clinically relevant effect on exposure. Weight changed -2.7 kg (0.75 mg) and -3.1 kg (1.5 mg) versus -1.5 kg on sitagliptin at 52 weeks; -2.9 kg on 1.5 mg versus -2.0 kg on placebo (difference -0.9 kg) as add-on to an SGLT2 inhibitor at 24 weeks; and -3.0, -3.8 and -4.6 kg on 1.5, 3 and 4.5 mg in the dose-ranging trial at 36 weeks from baselines near 95 kg.

Participants / model

Adults and children 10 years and older with type 2 diabetes; label PK participants; pooled placebo-controlled trial participants

Treatment

TRULICITY single-dose pen for subcutaneous injection, once weekly

Follow-up

Label version effective 16 June 2026; label trials of 24 to 52 weeks

Study design

FDA prescribing information

Funding

not stated in the source

Weight management is not a labeled indication. The label presents REWIND component results, including a hazard ratio of 0.76 for non-fatal stroke, as descriptive only, so they are not described here as significant. The retinopathy item is a warning with no incidence figure given here.

Regulatory record

U.S. Food and Drug Administration. Drugs@FDA application record for BLA 125469 (TRULICITY, Eli Lilly). Date read from the openFDA Drugs@FDA record on 10 October 2026.

FDA approved TRULICITY under BLA 125469 (Eli Lilly) on 18 September 2014.

Participants / model

Not a clinical population

Treatment

Biologics license application

Follow-up

Approved in 2014

Study design

FDA application record

Funding

not stated in the source

The record gives the approval date. Approvals outside the United States are not covered.

Randomized controlled trial

Dungan KM et al. Lancet. 2014;384(9951):1349-57. PMID 25018121.

At 26 weeks HbA1c fell 1.42% on dulaglutide versus 1.36% on liraglutide (difference -0.06%, 95% CI -0.19 to 0.07), meeting non-inferiority. Nausea occurred in 20% versus 18%, diarrhoea in 12% in each group and vomiting in 7% versus 8%. Adverse-event discontinuation was 6% in each group, and there was no severe hypoglycaemia.

Participants / model

599 metformin-treated adults with type 2 diabetes (HbA1c 7.0 to 10.0%, BMI 45 or lower), at 62 sites in nine countries

Treatment

Subcutaneous dulaglutide 1.5 mg weekly (299) versus liraglutide 1.8 mg daily (300)

Follow-up

26 weeks

Study design

Randomized open-label phase 3 non-inferiority trial (NCT01624259)

Funding

Funded by Lilly

Open-label, with an active comparator and no placebo arm.

Randomized controlled trial

Frias JP et al. Diabetes Care. 2021;44(3):765-773. PMID 33397768.

At 36 weeks, 4.5 mg lowered HbA1c more than 1.5 mg (treatment-regimen estimand -1.77% versus -1.54%, difference -0.24%) and weight more (-4.6 versus -3.0 kg, difference -1.6 kg). Nausea ran 13.4%, 15.6% and 16.4%, and vomiting 5.6%, 8.3% and 9.3%, across the three doses.

Participants / model

1,842 metformin-treated adults with type 2 diabetes (mean HbA1c 8.6%, BMI 34.2)

Treatment

Subcutaneous dulaglutide 1.5, 3.0 or 4.5 mg once weekly

Follow-up

52 weeks, with HbA1c and weight reported at 36 weeks

Study design

Randomized phase 3 dose comparison

Funding

not stated in the source

Lilly authors. The figures given are at 36 weeks.

Randomized controlled trial

Gerstein HC et al. Lancet. 2019;394(10193):121-130. PMID 31189511.

The primary composite (non-fatal myocardial infarction, non-fatal stroke, cardiovascular death) occurred in 594 (12.0%) versus 663 (13.4%), hazard ratio 0.88 (95% CI 0.79 to 0.99). All-cause death did not differ significantly (10.8% versus 12.0%, HR 0.90, 95% CI 0.80 to 1.01). Gastrointestinal adverse events were reported by 47.4% versus 34.1%.

Participants / model

9,901 people aged 50 or older with type 2 diabetes and prior cardiovascular disease or risk factors (mean age 66.2, median HbA1c 7.2%, 46.3% women), at 371 sites in 24 countries

Treatment

Subcutaneous dulaglutide 1.5 mg once weekly or placebo

Follow-up

Median 5.4 years

Study design

Randomized placebo-controlled cardiovascular outcomes trial (NCT01394952)

Funding

Funded by Lilly

The label gives REWIND component results, such as a hazard ratio of 0.76 for non-fatal stroke, as descriptive only.

Randomized controlled trial

Pratley RE et al. Lancet Diabetes Endocrinol. 2018;6(4):275-286. PMID 29397376.

Semaglutide beat dulaglutide at matched dose levels. At 40 weeks HbA1c fell 1.8 points on semaglutide 1.0 mg versus 1.4 on dulaglutide 1.5 mg, and weight fell 6.5 kg versus 3.0 kg (difference -3.55 kg, 95% CI -4.32 to -2.78). Gastrointestinal disorders occurred in 44% on semaglutide 1.0 mg and 48% on dulaglutide 1.5 mg.

Participants / model

1,201 adults with type 2 diabetes on metformin (HbA1c 7.0 to 10.5%)

Treatment

Subcutaneous semaglutide 0.5 or 1.0 mg versus dulaglutide 0.75 or 1.5 mg, once weekly

Follow-up

40 weeks

Study design

Randomized open-label phase 3b trial (NCT02648204)

Funding

not stated in the source

Dulaglutide was the comparator, so this is the head-to-head weight comparison, not a dulaglutide placebo trial.

Randomized controlled trial

Nicholls SJ et al. N Engl J Med. 2025;393(24):2409-2420. PMID 41406444.

The composite of cardiovascular death, myocardial infarction or stroke occurred in 12.2% on tirzepatide and 13.1% on dulaglutide (HR 0.92, 95.3% CI 0.83 to 1.01), non-inferior but not superior. More gastrointestinal adverse events occurred with tirzepatide.

Participants / model

13,165 adults with type 2 diabetes and atherosclerotic cardiovascular disease (modified intention-to-treat population)

Treatment

Subcutaneous tirzepatide up to 15 mg versus dulaglutide 1.5 mg, once weekly

Follow-up

not stated in the source

Study design

Randomized cardiovascular outcomes trial with dulaglutide as the active comparator

Funding

not stated in the source

Dulaglutide was the comparator, so this page uses it as context, not as a dulaglutide efficacy result.

Randomized controlled trial

Arslanian SA et al. N Engl J Med. 2022;387(5):433-443. PMID 35658022.

HbA1c rose 0.6 points on placebo and fell 0.6 and 0.9 points on dulaglutide, and 51% versus 14% reached HbA1c under 7.0%. BMI change did not differ between groups. Gastrointestinal events were more common on dulaglutide.

Participants / model

154 youths aged 10 to under 18 with type 2 diabetes and BMI above the 85th percentile

Treatment

Subcutaneous placebo, dulaglutide 0.75 mg or dulaglutide 1.5 mg, once weekly

Follow-up

26 weeks

Study design

Randomized placebo-controlled trial

Funding

not stated in the source

The 51% versus 14% figure is dulaglutide against placebo, as given in the source summary.

PubMed search record

Zhang Y et al. Nutrients. 2023;15(3). PMID 36771262.

The search returned 2 records: a smoking-cessation blood pressure analysis and one open-label trial of 68 overweight or obese women with polycystic ovary syndrome, in which dulaglutide plus a calorie-restricted diet reached 7% weight loss faster than diet alone but did not reduce visceral fat area more (difference -0.97 cm2, 95% CI -14.36 to 12.42). No obesity-indication trial of dulaglutide appeared.

Participants / model

Records reviewed; 68 women with polycystic ovary syndrome in the one weight trial

Treatment

Subcutaneous dulaglutide with a calorie-restricted diet

Follow-up

Search run on 10 October 2026

Study design

Literature search plus one small open-label randomized trial

Funding

not stated in the source

A search result shows what PubMed returned on that date. It is not proof that no unindexed study exists.