cagrilintide
Cagrilintide alone has randomized weight-loss evidence, including a direct phase 2 comparison with liraglutide and a monotherapy arm in REDEFINE-1. It remains distinct from CagriSema and has no FDA-approved standalone product.
Long-acting amylin and calcitonin receptor agonist
- Once-weekly investigational amylin analog
- Studied alone and as the cagrilintide component of CagriSema
- No FDA-approved monotherapy product found
Is cagrilintide approved as a standalone medicine?
FDA Drugs@FDA and openFDA records contained no exact-name cagrilintide standalone approval. Cagrilintide remains investigational as monotherapy even though it has been tested in phase 3 as a component arm.
FDA records · cagrilintide status
Regulatory database record set
FDA Drugs@FDA and openFDA records
The cited U.S. approval records contain no exact-name cagrilintide standalone entry.
- Participants / model
- United States drug approvals
- Treatment
- Cagrilintide
- Study design
- Exact-name U.S. approval coverage
What is the current status of the standalone RENEW phase 3 program?
The cited ClinicalTrials.gov records list two phase 3 weight-loss trials of standalone cagrilintide as active but no longer recruiting. RENEW 1 estimates 300 adults with overweight or obesity and RENEW 2 estimates 330 adults with overweight or obesity plus type 2 diabetes. Both list primary completion in May 2027 and have no posted results.
RENEW 4 began in August 2026 and was recruiting an estimated 285 adults with overweight or obesity. It is a phase 3 comparability study of two injectable versions and placebo, with estimated primary completion in May 2027. No weight-change or safety outcomes were posted.
| Study | Population | Status | Estimated enrollment | Primary completion |
|---|---|---|---|---|
| RENEW 1, NCT07220642 | Overweight or obesity | Active, not recruiting | 300 | May 11, 2027 |
| RENEW 2, NCT07220759 | Overweight or obesity with type 2 diabetes | Active, not recruiting | 330 | May 12, 2027 |
| RENEW 4, NCT07745504 | Overweight or obesity; formulation comparability | Recruiting | 285 | May 18, 2027 |
RENEW 1 · active, not recruiting
ClinicalTrials.gov registry record
ClinicalTrials.gov NCT07220642.
Active, not recruiting; estimated enrollment 300; actual start November 5, 2025; estimated primary completion May 11, 2027; no results posted.
- Participants / model
- Adults with overweight or obesity
- Treatment
- Weekly standalone injectable cagrilintide under the registry protocol versus placebo or formulation comparator
- Follow-up
- Estimated study completion June 29, 2027
- Study design
- Phase 3 interventional trial registry entry; registry-only, without posted results
- Funding
- Novo Nordisk
Enrollment and completion dates are estimates, and the registry had no posted outcomes.
Read the original sourceRENEW 2 · active, not recruiting
ClinicalTrials.gov registry record
ClinicalTrials.gov NCT07220759.
Active, not recruiting; estimated enrollment 330; actual start November 5, 2025; estimated primary completion May 12, 2027; no results posted.
- Participants / model
- Adults with overweight or obesity and type 2 diabetes
- Treatment
- Weekly standalone injectable cagrilintide under the registry protocol versus placebo or formulation comparator
- Follow-up
- Estimated study completion June 30, 2027
- Study design
- Phase 3 interventional trial registry entry; registry-only, without posted results
- Funding
- Novo Nordisk
This diabetes population is different from RENEW 1 and the earlier phase 2 population. Enrollment and dates remain estimates.
Read the original sourceRENEW 4 · recruiting
ClinicalTrials.gov registry record
ClinicalTrials.gov NCT07745504.
Recruiting; estimated enrollment 285; actual start August 4, 2026; estimated primary completion May 18, 2027; no results posted.
- Participants / model
- Adults with overweight or obesity in a formulation-comparability study
- Treatment
- Weekly standalone injectable cagrilintide under the registry protocol versus placebo or formulation comparator
- Follow-up
- Estimated study completion July 6, 2027
- Study design
- Phase 3 interventional trial registry entry; registry-only, without posted results
- Funding
- Novo Nordisk
This study compares injectable cagrilintide formulations and placebo; no efficacy results were posted.
Read the original sourceWhat did the standalone phase 2 trial show?
At week 26 under the trial-product estimand, mean weight reduction ranged from 6.0% to 10.8% across cagrilintide doses versus 3.0% with placebo. At 4.5 mg, cagrilintide produced 10.8% versus 9.0% with liraglutide 3.0 mg daily, an estimated 1.8 percentage-point difference.
The active treatments were not masked from one another. The trial assumed adherence for its featured estimand and lasted 26 weeks.
Cagrilintide phase 2 · placebo and liraglutide
Randomized trial
Lau et al., The Lancet, 2021
In 706 randomized adults, cagrilintide produced dose-dependent weight loss; 4.5 mg produced 10.8% versus 9.0% with liraglutide and 3.0% with placebo, while the abstract reports pooled discontinuation and withdrawal totals.
- Participants / model
- Adults without diabetes with obesity, or overweight plus hypertension or dyslipidemia
- Treatment
- Weekly cagrilintide dose groups, daily liraglutide 3.0 mg, or placebo
- Follow-up
- 26 weeks plus 6-week follow-up
- Study design
- Randomized, placebo- and active-controlled dose-finding phase 2 trial
- Funding
- Novo Nordisk
Active drugs were distinguishable by schedule, and the featured result assumes adherence.
Read the original sourceWhat does the REDEFINE-1 monotherapy arm add?
In the 68-week phase 3 trial, cagrilintide 2.4 mg produced -11.5% mean weight change under the treatment-policy estimand versus -3.0% with placebo. An adherence-assuming analysis reported -11.8% versus -2.3%. These are separate from the CagriSema combination result.
The 10.8% and 11.5% values come from different doses, durations, trials, and estimands.
REDEFINE-1 · monotherapy context
Randomized trial
Garvey et al., New England Journal of Medicine, 2025
The phase 3 trial included a 302-person cagrilintide monotherapy arm and reported -11.5% mean week-68 change under the treatment-policy estimand.
- Participants / model
- Adults with obesity or overweight plus a complication, without diabetes
- Treatment
- Cagrilintide 2.4 mg, CagriSema, semaglutide, or placebo
- Follow-up
- 68 weeks
- Study design
- Randomized, double-blind, placebo- and active-controlled phase 3 trial
- Funding
- Novo Nordisk
Cagrilintide monotherapy and the fixed combination are different interventions.
Read the original sourceWhat did monotherapy tolerability look like?
In phase 2, gastrointestinal events occurred in 41% to 63% across cagrilintide doses versus 32% with placebo, with nausea in 20% to 47% versus 18%. Across all 706 randomized groups, permanent treatment discontinuation occurred in 73 participants (10%), mostly because of adverse events in 30 (4%); 29 (4%) withdrew from the trial.
Those discontinuation values combine cagrilintide, liraglutide, and placebo groups because the abstract does not provide an arm-specific breakdown. REDEFINE-1 combination safety should not be assigned to cagrilintide monotherapy.
Cagrilintide phase 2 · placebo and liraglutide
Randomized trial
Lau et al., The Lancet, 2021
In 706 randomized adults, cagrilintide produced dose-dependent weight loss; 4.5 mg produced 10.8% versus 9.0% with liraglutide and 3.0% with placebo, while the abstract reports pooled discontinuation and withdrawal totals.
- Participants / model
- Adults without diabetes with obesity, or overweight plus hypertension or dyslipidemia
- Treatment
- Weekly cagrilintide dose groups, daily liraglutide 3.0 mg, or placebo
- Follow-up
- 26 weeks plus 6-week follow-up
- Study design
- Randomized, placebo- and active-controlled dose-finding phase 2 trial
- Funding
- Novo Nordisk
Active drugs were distinguishable by schedule, and the featured result assumes adherence.
Read the original sourceREDEFINE-1 · monotherapy safety details
Sponsor scientific poster
Garvey et al., EASD, 2025
Reports cagrilintide monotherapy gastrointestinal-event frequencies and adherence-assuming weight estimates from REDEFINE-1.
- Participants / model
- 302 adults in the cagrilintide arm; 705 placebo participants
- Treatment
- Cagrilintide 2.4 mg weekly or placebo
- Follow-up
- 68 weeks
- Study design
- Prespecified and supportive analyses from a randomized phase 3 trial
These details come from a sponsor scientific poster rather than the peer-reviewed article.
Read the original sourceDoes amylin-receptor activity predict better tolerability or durability?
Cagrilintide is engineered for long action at amylin and calcitonin receptors and is intended to increase satiety. Receptor design does not predict an individual response, remove gastrointestinal effects, or establish what happens after stopping.
Cagrilintide phase 2 · placebo and liraglutide
Randomized trial
Lau et al., The Lancet, 2021
In 706 randomized adults, cagrilintide produced dose-dependent weight loss; 4.5 mg produced 10.8% versus 9.0% with liraglutide and 3.0% with placebo, while the abstract reports pooled discontinuation and withdrawal totals.
- Participants / model
- Adults without diabetes with obesity, or overweight plus hypertension or dyslipidemia
- Treatment
- Weekly cagrilintide dose groups, daily liraglutide 3.0 mg, or placebo
- Follow-up
- 26 weeks plus 6-week follow-up
- Study design
- Randomized, placebo- and active-controlled dose-finding phase 2 trial
- Funding
- Novo Nordisk
Active drugs were distinguishable by schedule, and the featured result assumes adherence.
Read the original sourceStudies and sources
FDA records · cagrilintide status
Regulatory database record set
FDA Drugs@FDA and openFDA records
The cited U.S. approval records contain no exact-name cagrilintide standalone entry.
- Participants / model
- United States drug approvals
- Treatment
- Cagrilintide
- Study design
- Exact-name U.S. approval coverage
Cagrilintide phase 2 · placebo and liraglutide
Randomized trial
Lau et al., The Lancet, 2021
In 706 randomized adults, cagrilintide produced dose-dependent weight loss; 4.5 mg produced 10.8% versus 9.0% with liraglutide and 3.0% with placebo, while the abstract reports pooled discontinuation and withdrawal totals.
- Participants / model
- Adults without diabetes with obesity, or overweight plus hypertension or dyslipidemia
- Treatment
- Weekly cagrilintide dose groups, daily liraglutide 3.0 mg, or placebo
- Follow-up
- 26 weeks plus 6-week follow-up
- Study design
- Randomized, placebo- and active-controlled dose-finding phase 2 trial
- Funding
- Novo Nordisk
Active drugs were distinguishable by schedule, and the featured result assumes adherence.
Read the original sourceREDEFINE-1 · monotherapy context
Randomized trial
Garvey et al., New England Journal of Medicine, 2025
The phase 3 trial included a 302-person cagrilintide monotherapy arm and reported -11.5% mean week-68 change under the treatment-policy estimand.
- Participants / model
- Adults with obesity or overweight plus a complication, without diabetes
- Treatment
- Cagrilintide 2.4 mg, CagriSema, semaglutide, or placebo
- Follow-up
- 68 weeks
- Study design
- Randomized, double-blind, placebo- and active-controlled phase 3 trial
- Funding
- Novo Nordisk
Cagrilintide monotherapy and the fixed combination are different interventions.
Read the original sourceREDEFINE-1 · monotherapy safety details
Sponsor scientific poster
Garvey et al., EASD, 2025
Reports cagrilintide monotherapy gastrointestinal-event frequencies and adherence-assuming weight estimates from REDEFINE-1.
- Participants / model
- 302 adults in the cagrilintide arm; 705 placebo participants
- Treatment
- Cagrilintide 2.4 mg weekly or placebo
- Follow-up
- 68 weeks
- Study design
- Prespecified and supportive analyses from a randomized phase 3 trial
These details come from a sponsor scientific poster rather than the peer-reviewed article.
Read the original sourceRENEW 1 · active, not recruiting
ClinicalTrials.gov registry record
ClinicalTrials.gov NCT07220642.
Active, not recruiting; estimated enrollment 300; actual start November 5, 2025; estimated primary completion May 11, 2027; no results posted.
- Participants / model
- Adults with overweight or obesity
- Treatment
- Weekly standalone injectable cagrilintide under the registry protocol versus placebo or formulation comparator
- Follow-up
- Estimated study completion June 29, 2027
- Study design
- Phase 3 interventional trial registry entry; registry-only, without posted results
- Funding
- Novo Nordisk
Enrollment and completion dates are estimates, and the registry had no posted outcomes.
Read the original sourceRENEW 2 · active, not recruiting
ClinicalTrials.gov registry record
ClinicalTrials.gov NCT07220759.
Active, not recruiting; estimated enrollment 330; actual start November 5, 2025; estimated primary completion May 12, 2027; no results posted.
- Participants / model
- Adults with overweight or obesity and type 2 diabetes
- Treatment
- Weekly standalone injectable cagrilintide under the registry protocol versus placebo or formulation comparator
- Follow-up
- Estimated study completion June 30, 2027
- Study design
- Phase 3 interventional trial registry entry; registry-only, without posted results
- Funding
- Novo Nordisk
This diabetes population is different from RENEW 1 and the earlier phase 2 population. Enrollment and dates remain estimates.
Read the original sourceRENEW 4 · recruiting
ClinicalTrials.gov registry record
ClinicalTrials.gov NCT07745504.
Recruiting; estimated enrollment 285; actual start August 4, 2026; estimated primary completion May 18, 2027; no results posted.
- Participants / model
- Adults with overweight or obesity in a formulation-comparability study
- Treatment
- Weekly standalone injectable cagrilintide under the registry protocol versus placebo or formulation comparator
- Follow-up
- Estimated study completion July 6, 2027
- Study design
- Phase 3 interventional trial registry entry; registry-only, without posted results
- Funding
- Novo Nordisk
This study compares injectable cagrilintide formulations and placebo; no efficacy results were posted.
Read the original sourceWhy is cagrilintide in B tier?
B tier is based on cagrilintide monotherapy results from phase 2 and the REDEFINE-1 phase 3 arm. CagriSema's combination effect does not belong to cagrilintide alone, and no standalone dose is FDA approved.