chapter 16 of 52 · the reptides guide
Liraglutide
A daily GLP-1 medicine used to treat type 2 diabetes and obesity.
Mechanism and effects
Liraglutide acts at the GLP-1 receptor. It reduces food intake and slows stomach emptying; its effect on insulin release depends on glucose levels. Low blood sugar can still occur, especially alongside insulin or a sulfonylurea.429
| Product | What the US label covers |
|---|---|
| Saxenda | Chronic weight management in eligible adults and adolescents aged 12 and older. |
| Victoza | Type 2 diabetes from age 10; cardiovascular risk reduction in adults with type 2 diabetes and established cardiovascular disease. |
| Xultophy | Insulin degludec plus liraglutide. Evidence and precautions for a combination cannot be treated as those of liraglutide alone. |
Approved and compounded products
FDA reviews generic drug applications. Compounded preparations are not FDA-approved products.431,432
How much weight was lost?
SCALE compared liraglutide with placebo; STEP 8 compared it with semaglutide.
8.4 kg versus 2.8 kg
Among 3,731 adults without type 2 diabetes, average weight loss was 8.4 kg with liraglutide and 2.8 kg with placebo. Both groups received lifestyle counseling. At least 5% loss occurred in 63.2% and 27.1%, respectively. The analysis carried forward the last available observation for missing measurements.433
6.4% versus 15.8%
Average weight loss was 6.4% with daily liraglutide and 15.8% with weekly semaglutide. The trial enrolled 338 adults without diabetes: 127 received liraglutide, 126 semaglutide and 85 pooled placebo. The active-drug comparison was open label.434
Treatment discontinuation
In STEP 8, 27.6% assigned liraglutide discontinued treatment for any reason, compared with 13.5% assigned semaglutide. Gastrointestinal effects were common with both.434
How certain is the wider evidence?
A 2025 Cochrane review included 24 trials and 9,937 participants. Evidence that liraglutide increased the chance of losing at least 5% of body weight was rated moderate certainty; the pooled percentage-weight-change estimate was very low certainty. Most trials were funded by the manufacturer.435
What happens after stopping?
Weight management often needs continued treatment and follow-up. Regain was seen after liraglutide stopped.
9.6 kg regained
In S-LiTE, 195 adults were randomized after an initial diet-induced weight loss. During the year after treatment ended, model-estimated regain was 9.6 kg after liraglutide alone, 7.1 kg after liraglutide plus supervised exercise and 3.6 kg after exercise alone.436
Follow-up and uncertainty
Only 109 participants attended the off-treatment visit; 166 had completed treatment. The combination-versus-liraglutide comparison over the full two years did not pass the study's adjustment for multiple comparisons.436
Teenagers also regained after withdrawal
In the adolescent trial, BMI standard-deviation score rose more after liraglutide stopped than after placebo stopped during the 26-week follow-up. This measure adjusts BMI for age and sex.437
Daily treatment can be hard to sustain
A retrospective US claims study reported one-year persistence of 40.4% for liraglutide and 67% for semaglutide among people with type 2 diabetes. The treatment groups differed at baseline.438
Heart benefits have a defined scope
The strongest cardiovascular result comes from people with type 2 diabetes and high cardiovascular risk.
13.0% versus 14.9%
Among 9,340 participants followed for a median of 3.8 years, cardiovascular death, nonfatal heart attack or nonfatal stroke occurred in 13.0% with liraglutide and 14.9% with placebo. The hazard ratio was 0.87, with a 95% confidence interval of 0.78 to 0.97.439
Heart failure
LEADER did not significantly reduce heart-failure hospitalization. In FIGHT, 300 people recently hospitalized with reduced-ejection-fraction heart failure had no improvement in the main clinical-stability outcome. In the smaller LIVE trial, ejection fraction did not improve; heart rate and serious cardiac events were higher with liraglutide.439,440,441
Visceral fat
An imaging trial randomized 185 adults and obtained follow-up scans in 128. Visceral fat fell more with liraglutide than placebo.442
Children and teenagers
Product labels set age and body-weight criteria for children and teenagers.
BMI fell; weight still rose
The 82-participant trial in children aged 6 to less than 12 found a 56-week BMI change of -5.8% with liraglutide and +1.6% with placebo. Body weight changed by +1.6% and +10.0%.443
The adolescent trial
Among 251 participants aged 12 to less than 18, liraglutide reduced BMI standard-deviation score more than placebo over 56 weeks. Gastrointestinal events occurred in 64.8% versus 36.5%; 10.4% stopped liraglutide because of adverse events, compared with none on placebo.437
| Country or region | Boundary |
|---|---|
| United States | Age 12 and older, with the label's eligibility criteria. |
| European Union | Also includes eligible children aged 6 to less than 12 with obesity and body weight of at least 45 kg. |
| New Zealand | The August 2026 data sheet remains adult-only. |
Liver disease and cognition
Trials have also explored liver disease and Alzheimer disease.
9 of 23 versus 2 of 22
The small trial randomized 52 adults with NASH. Among those with endpoint biopsies, resolution without worsening fibrosis occurred in 9 of 23 liraglutide participants and 2 of 22 placebo participants at 48 weeks.446
Primary outcome not met
In 204 people with mild to moderate Alzheimer disease without diabetes, liraglutide did not significantly improve the main brain glucose-metabolism outcome. A secondary cognitive score favored liraglutide with an unadjusted P value; other clinical measures did not.447
Regional studies
These records cover stroke, adolescent obesity and liver markers.
China: a small stroke study
A Chinese journal abstract describes 100 people with a first acute cerebral infarction and type 2 diabetes, randomized into two groups of 50. It reports glucose, neurological-score and imaging differences, but does not provide the comparator treatment, duration, blinding or exact effect sizes.462
Russia: adolescent experience
A prospective cohort enrolled 17 teenagers with obesity. Six stopped early; the reported 12-month improvements came from 11 completers. The study had no comparison group.463
Russia: liver markers
A retrospective study compared 19 liraglutide users with 16 dulaglutide users who had diabetes, obesity and fatty liver disease. FIB-4 changed in the liraglutide group, but measured fibrosis markers did not change.464
Japan: Victoza label
The May 2026 Japanese Victoza label is for type 2 diabetes and states that pediatric clinical trials were not conducted.465
Common effects and serious warnings
The trial rates below come from the adult Saxenda program.
| Event | Liraglutide / placebo |
|---|---|
| Nausea | 39.3% / 13.8% |
| Vomiting | 15.7% / 3.9% |
| Severe gastrointestinal reactions | 4.8% / 1.4% |
| Gallstones | 2.2% / 0.8% |
| Cholecystitis | 0.8% / 0.4% |
Thyroid warning
The US boxed warning concerns thyroid C-cell tumors in rodents; human relevance is unknown. The label contraindicates use with a personal or family history of medullary thyroid carcinoma or MEN 2.429
Other warnings to discuss
The label also covers pancreatitis, gallbladder disease, dehydration-related kidney injury, increased heart rate, severe gastrointestinal reactions, hypersensitivity and aspiration during anesthesia. The label gives no universal preoperative hold interval. Weight-management treatment is discontinued when pregnancy is recognized.429
Suicide-warning changes
In January 2026, FDA requested removal of suicidal-behavior and ideation warning language after its class-wide review found no increased risk.448
What changed in the eye warnings?
Australia and New Zealand added an optic-nerve warning in 2026.
Australia and New Zealand
Australia's July 2026 update and New Zealand's August 2026 Saxenda sheet include reported NAION, an optic-nerve disorder. Australia listed three liraglutide reports within a wider group of optic ischaemic neuropathy reports. They do not show how often a drug causes an event.449,445
The pooled trial analysis
A 2026 analysis pooled liraglutide and semaglutide trial data from 96,829 participants. It found three confirmed cases in three treated participants and five cases in four placebo participants.450
Availability, recalls and compounding
Product and jurisdiction details as of September 30, 2026.
| Record | What it says |
|---|---|
| United States, Saxenda | Limited availability; planned discontinuation in January 2027. Some generic liraglutide presentations are listed as available. |
| European Union, Saxenda | The shortage notice was marked resolved in September 2026. |
| EU and EEA, Victoza | Commercial discontinuation by the end of 2026, with national dates varying. The notice does not attribute it to a safety or quality problem. |
The 2026 recall is lot specific
FDA records include an ongoing Class II recall of specified generic liraglutide pen batches for particulate matter. Match a recall to the exact product and lot.454
US compounding proposal
FDA proposed excluding liraglutide from the 503B bulks list in April 2026, then extended comments to July 30. The cited records do not include a final decision.455,456,457
Australia's compounding restriction
TGA guidance updated September 8, 2026 states that pharmacists must not compound GLP-1 receptor agonist analogues from October 1, 2024.458
Common questions
Availability, side effects, restarting and what happens after stopping.
01 Is Saxenda being discontinued, and what liraglutide products are still available?
Saxenda has limited US availability and FDA records list a planned US discontinuation in January 2027, while some generic liraglutide products are available. EMA says the Saxenda shortage in the EU is resolved, but Victoza is being commercially discontinued across the EU and EEA by the end of 2026.451,452,453
02 How does daily liraglutide compare with weekly semaglutide?
STEP 8 enrolled 338 adults without diabetes: 127 received daily liraglutide, 126 received weekly semaglutide, and 85 received matched placebo. At 68 weeks, mean weight change was -6.4% with liraglutide and -15.8% with semaglutide, and discontinuation for any reason was more common with liraglutide. The active comparison was open label and does not decide which medicine fits one person.434
03 How much weight do people lose with liraglutide?
In SCALE, 3,731 adults without type 2 diabetes were randomized for 56 weeks. Mean weight loss was 8.4 kg with liraglutide and 2.8 kg with placebo, and 63.2% versus 27.1% lost at least 5%. The figures describe randomized groups under last-observation-carried-forward analysis and do not predict an individual result.433
04 What serious warnings matter?
The Saxenda label keeps a boxed warning about thyroid C-cell tumors in rodents and contraindicates use with personal or family medullary thyroid cancer or MEN 2. Other serious issues include pancreatitis, gallbladder disease, dehydration-related kidney injury, severe stomach or bowel symptoms, hypersensitivity and aspiration during anesthesia. Regulators also added postmarketing NAION, a rare optic-nerve disorder, to some country labels, but no liraglutide incidence rate has been established.429,459,449,445
05 Is Saxenda the same as Victoza or generic liraglutide?
Saxenda and Victoza contain liraglutide, but they are separate products with different approved uses, age criteria and clinical records. FDA records also list generic liraglutide products, with approved uses defined by the reference product and applicable label. Compounded or unapproved products are a separate category and are not made equivalent by using the same ingredient name.429,430,431,432
06 Why are nausea, constipation, and vomiting so common?
Liraglutide reduces energy intake and slows gastric emptying, which can also produce nausea, constipation and vomiting. In pooled adult Saxenda weight-management trials, nausea was reported in 39.3% versus 13.8% with placebo and vomiting in 15.7% versus 3.9%. Trial averages do not predict how severe or persistent symptoms will be for one person.429
07 How long does it take to work, and when should benefit be reassessed?
There is no single reassessment clock across every liraglutide product and country. The US Saxenda label uses a 4% body-weight threshold at week 16 for adults and a 1% BMI threshold after 12 weeks at maintenance for patients age 12 and older; the EU label uses different BMI and weight rules. A prescriber interprets these product-label checkpoints; they do not predict when one individual will notice an effect.429,444
08 How should the pen be stored, and what if it jams or gets warm?
The Saxenda label says unused pens are refrigerated, while a pen in use may be kept for 30 days either refrigerated or at 15 to 30°C, and a frozen pen should not be used. Its instructions also treat a blocked or damaged needle as a device problem and say not to repair or dismantle the pen. Other liraglutide products can have different devices and handling instructions, so the exact product label controls.429,460
09 Can I use liraglutide during pregnancy or breastfeeding?
The Saxenda weight-management label says to discontinue the product when pregnancy is recognized because weight loss offers no benefit in pregnancy and may cause fetal harm. It also says there are no human data on liraglutide in breast milk, effects on a breastfed infant or milk production. Pregnancy and breastfeeding decisions need product-specific review with the prescriber.429
10 How does liraglutide reduce appetite?
Liraglutide activates the GLP-1 receptor. It lowers energy intake, supports glucose-dependent insulin release, suppresses inappropriate glucagon release and slows gastric emptying. Those actions help explain both appetite effects and common gastrointestinal symptoms.429
11 Does Victoza lower heart risk for everyone with diabetes?
No. LEADER studied 9,340 adults with type 2 diabetes and high cardiovascular risk, and the primary cardiovascular outcome occurred in 13.0% with liraglutide versus 14.9% with placebo. The Victoza cardiovascular indication applies to that defined population; this result does not establish event prevention for all people using liraglutide for weight management.439,430
12 What happens to weight after stopping?
Weight regain occurred after treatment stopped in both adult and adolescent trials. In S-LiTE, 109 of 195 initially randomized adults attended the one-year off-treatment visit, and model-estimated regain after liraglutide alone was 9.6 kg; the adolescent trial also showed more BMI standard-deviation-score regain in the former liraglutide group over 26 weeks. Attrition and the selected trial populations mean these results cannot predict one person's amount or timing.436,437
13 What do we know in children and teenagers?
The US Saxenda label covers patients age 12 and older, while the EU label also covers children age 6 to under 12 with obesity and body weight of at least 45 kg. In the adolescent trial, liraglutide improved BMI standard-deviation score at 56 weeks, but stomach and bowel events and treatment discontinuations were more common. Age limits and reassessment rules differ by country, so one label should not be treated as global.429,444,437
14 What if I miss doses or restart after a break?
The Saxenda label says not to make up a missed dose with extra medicine and tells patients who have missed three days or more to contact their prescriber about restarting. A restart plan belongs to the exact product and patient. The label does not support a universal catch-up rule across liraglutide products.429
15 What should I know before surgery or anesthesia?
The Saxenda label reports rare aspiration during general anesthesia or deep sedation and says evidence is insufficient to know whether fasting changes or temporary discontinuation reduces risk. It gives no universal hold interval. The procedure team has to set the plan for the exact patient and procedure.429,461
sources for this chapter
- Saxenda: FDA labeling attached to supplement 24, June 2026 Checked September 30, 2026. Selected primary-source passages reviewed.
- Current DailyMed Victoza prescribing information, revised October 2025 Checked September 30, 2026. Selected primary-source passages reviewed.
- Drugs@FDA liraglutide application and label-history query Checked September 30, 2026. Selected primary-source passages reviewed.
- FDA concerns with unapproved GLP-1 drugs used for weight loss Checked September 30, 2026. Selected primary-source passages reviewed.
- A Randomized, Controlled Trial of 3.0 mg of Liraglutide in Weight Management. Checked September 30, 2026. Abstract reviewed.
- Effect of Weekly Subcutaneous Semaglutide vs Daily Liraglutide on Body Weight in Adults With Overweight or Obesity Without Diabetes: The STEP 8 Randomized Clinical Trial. Checked September 30, 2026. Abstract reviewed.
- Liraglutide for adults living with obesity. Checked September 30, 2026. Abstract reviewed.
- Healthy weight loss maintenance with exercise, GLP-1 receptor agonist, or both combined followed by one year without treatment: a post-treatment analysis of a randomised placebo-controlled trial. Checked September 30, 2026. Selected methods and results reviewed.
- A Randomized, Controlled Trial of Liraglutide for Adolescents with Obesity. Checked September 30, 2026. Abstract reviewed.
- Semaglutide Once-Weekly Persistence and Adherence Versus Other GLP-1 RAs in Patients with Type 2 Diabetes in a US Real-World Setting. Checked September 30, 2026. Abstract reviewed.
- Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes. Checked September 30, 2026. Abstract reviewed.
- Effects of Liraglutide on Clinical Stability Among Patients With Advanced Heart Failure and Reduced Ejection Fraction: A Randomized Clinical Trial. Checked September 30, 2026. Abstract reviewed.
- Effect of liraglutide, a glucagon-like peptide-1 analogue, on left ventricular function in stable chronic heart failure patients with and without diabetes (LIVE)-a multicentre, double-blind, randomised, placebo-controlled trial. Checked September 30, 2026. Abstract reviewed.
- Effects of liraglutide on visceral and ectopic fat in adults with overweight and obesity at high cardiovascular risk: a randomised, double-blind, placebo-controlled, clinical trial. Checked September 30, 2026. Abstract reviewed.
- Liraglutide for Children 6 to <12 Years of Age with Obesity - A Randomized Trial. Checked September 30, 2026. Abstract reviewed.
- EMA Saxenda summary of product characteristics Checked September 30, 2026. Selected primary-source passages reviewed.
- New Zealand Saxenda data sheet, revised August 27, 2026 Checked September 30, 2026. Selected primary-source passages reviewed.
- Liraglutide safety and efficacy in patients with non-alcoholic steatohepatitis (LEAN): a multicentre, double-blind, randomised, placebo-controlled phase 2 study. Checked September 30, 2026. Abstract reviewed.
- Liraglutide in mild to moderate Alzheimer's disease: a phase 2b clinical trial. Checked September 30, 2026. Abstract reviewed.
- FDA requests removal of suicidal-behavior and ideation warning from GLP-1 medicines Checked September 30, 2026. Selected primary-source passages reviewed.
- TGA: GLP-1 receptor agonists and a rare vision disorder Checked September 30, 2026. Selected primary-source passages reviewed.
- Non-arteritic anterior ischaemic optic neuropathy incidence in placebo-controlled clinical trials of liraglutide or semaglutide. Checked September 30, 2026. Abstract reviewed.
- FDA current liraglutide shortage and discontinuation records Checked September 30, 2026. Selected primary-source passages reviewed.
- EMA Saxenda resolved shortage notice Checked September 30, 2026. Selected primary-source passages reviewed.
- EMA Victoza shortage and EU/EEA discontinuation notice Checked September 30, 2026. Selected primary-source passages reviewed.
- FDA liraglutide enforcement report query Checked September 30, 2026. Selected primary-source passages reviewed.
- FDA proposal to exclude liraglutide, semaglutide and tirzepatide from the 503B bulks list Checked September 30, 2026. Selected primary-source passages reviewed.
- FDA 503B liraglutide proposal: comment-period extension Checked September 30, 2026. Selected primary-source passages reviewed.
- Federal Register exact liraglutide search Checked September 30, 2026. Selected primary-source passages reviewed.
- TGA lawful compounding guidance, updated September 8, 2026 Checked September 30, 2026. Selected primary-source passages reviewed.
- MHRA: strengthened GLP-1 pancreatitis warnings, January 29, 2026 Checked September 30, 2026. Selected primary-source passages reviewed.
- FDA Saxenda supplement 24 approval letter, June 2, 2026 Checked September 30, 2026. Selected primary-source passages reviewed.
- Health Canada GLP-1 pulmonary aspiration safety review Checked September 30, 2026. Selected primary-source passages reviewed.
- Clinical study of white-matter fiber-tract changes in acute cerebral infarction with type 2 diabetes treated with liraglutide 2022. Checked September 30, 2026. Abstract reviewed.
- Experience using liraglutide in adolescents with exogenous constitutional obesity: analysis of clinical outcomes 2025. Checked September 30, 2026. Full text reviewed.
- Direct comparison of liraglutide and dulaglutide effects on fibrosis scores and markers 2021. Checked September 30, 2026. Full text reviewed.
- Victoza subcutaneous injection 18 mg, Japanese package insert, revision 5 2026. Checked September 30, 2026. Selected label sections reviewed.
research reference, not medical advice. The Reptides Guide: Edition 1, October 2026 / Working draft.