Cagrilintide, alone and combined with semaglutide, has been studied for weight reduction in randomised trials.
What is not established
Programme readouts have been revised. Verify the specific trial and arm before relying on any figure.
Supporting sources (5)
Coadministered Cagrilintide and Semaglutide in Adults with Overweight or Obesity (REDEFINE 1)
Garvey WT, Blüher M, Osorto Contreras CK, et al. · New England Journal of Medicine · 2025 · n = 3,417
- Population
- Adults with BMI ≥30, or ≥27 with at least one obesity-related complication; without type 2 diabetes
- Endpoint
- Percentage change in body weight to week 68, and the proportion achieving at least 5% reduction
- Route
- Subcutaneous
- Quantity as reported
- Cagrilintide 2.4 mg with semaglutide 2.4 mg, each once weekly, reached by week 16 from a 0.25 mg start with steps every 4 weeks
- Frequency
- Once weekly
- Duration
- 68 weeks
Result. Body weight changed by −20.4% with the combination versus −3.0% with placebo on the treatment-policy estimand, a difference of −17.3 percentage points. Semaglutide alone reached −14.9% and cagrilintide alone −11.5% in the same trial.
Adverse events. Gastrointestinal events predominated and were most frequent during escalation, consistent with both drug classes.
Limitations. Excluded type 2 diabetes. The widely quoted −22.7% figure is the trial-product estimand, which models full adherence, and is not the primary result. Sixty-eight weeks says nothing about what happens on discontinuation.
Cagrilintide and Semaglutide in Adults with Overweight or Obesity and Type 2 Diabetes (REDEFINE 2)
Davies MJ, et al.; REDEFINE 2 Study Group · New England Journal of Medicine · 2025 · n = 1,206
- Population
- Adults with overweight or obesity and type 2 diabetes, across 12 countries
- Endpoint
- Percentage change in body weight to week 68, and the proportion achieving at least 5% reduction
- Route
- Subcutaneous
- Quantity as reported
- Cagrilintide 2.4 mg with semaglutide 2.4 mg, each once weekly, escalated 0.25 → 0.5 → 1.0 → 1.7 → 2.4 mg at 4-week steps
- Frequency
- Once weekly
- Duration
- 68 weeks
Result. Body weight changed by −13.7% versus −3.4% with placebo, a difference of −10.4 percentage points. The effect is materially smaller than in the population without diabetes.
Adverse events. Gastrointestinal events consistent with the incretin and amylin classes.
Limitations. The gap between this result and REDEFINE 1 is the finding worth carrying: the same schedule in a diabetic population produced roughly two-thirds of the weight change.
Efficacy and safety of co-administered once-weekly cagrilintide 2.4 mg with once-weekly semaglutide 2.4 mg in type 2 diabetes: a multicentre, randomised, double-blind, active-controlled, phase 2 trial
Frias JP, Deenadayalan S, Erichsen L, et al. · The Lancet · 2023 · n = 92
- Population
- Adults with type 2 diabetes, BMI ≥27, on metformin with or without an SGLT2 inhibitor
- Endpoint
- Change in HbA1c from baseline to week 32
- Route
- Subcutaneous
- Quantity as reported
- Cagrilintide 2.4 mg with semaglutide 2.4 mg, each once weekly after escalation
- Frequency
- Once weekly
- Duration
- 32 weeks
Result. HbA1c fell 2.2 percentage points with the combination versus 1.8 with semaglutide alone, which did not reach significance. Body weight fell 15.6% versus 5.1% and 8.1%, which did.
Adverse events. Gastrointestinal, dose-escalation related.
Limitations. Ninety-two participants across three arms. This is the dose-ranging ancestor of the phase 3 programme, not a basis for practice.
Once-weekly cagrilintide for weight management in people with overweight and obesity: a multicentre, randomised, double-blind, placebo-controlled and active-controlled, dose-finding phase 2 trial
Lau DCW, Erichsen L, Francisco AM, et al. · The Lancet · 2021 · n = 706
- Population
- Adults with overweight or obesity without diabetes, across 57 sites
- Endpoint
- Percentage change in body weight to week 26
- Route
- Subcutaneous
- Quantity as reported
- Cagrilintide 0.3, 0.6, 1.2, 2.4 or 4.5 mg once weekly, escalated in steps every 2 weeks to the assigned final amount
- Frequency
- Once weekly
- Duration
- 26 weeks
Result. Weight change ranged from −6.0% at 0.3 mg to −10.8% at 4.5 mg, against −3.0% for placebo. The 4.5 mg arm beat liraglutide 3.0 mg at −9.0%.
Adverse events. Gastrointestinal events, dose related.
Limitations. This is the only trial that establishes what cagrilintide does on its own. Note that the amount taken forward into the combination programme was 2.4 mg, not the 4.5 mg that performed best here.
Cagrilintide and cagrilintide/semaglutide combination trials
Multiple · The Lancet and New England Journal of Medicine programmes · 2023
- Population
- Adults with overweight or obesity
- Endpoint
- Percentage change in body weight
- Route
- Subcutaneous
- Quantity as reported
- Reported per registered trial arm
- Frequency
- Once weekly
- Duration
- 68 weeks
Result. The amylin analogue alone and in combination with semaglutide reported greater weight reduction than semaglutide alone in the programmes reported.
Adverse events. Gastrointestinal events consistent with the incretin/amylin classes.
Limitations. Verify the specific trial and arm before citing a figure. Combination programmes are ongoing and readouts continue to change.
Last evidence review: 2026-08-23