What Is Cagrilintide? Trials and FDA Status

Cagrilintide Approval Status

Cagrilintide is not approved by the FDA. No FDA-approved cagrilintide product exists, and no commercial price, label or dosing guidance exists.

Cagrilintide is being evaluated alongside semaglutide in the investigational combination product CagriSema. According to a Novo Nordisk regulatory announcement, Novo Nordisk submitted an application to the FDA for CagriSema for weight management in December 2025. Novo Nordisk stated that an FDA regulatory decision is anticipated by late 2026.

Mechanism of Action as an Amylin Analogue

Cagrilintide is a long-acting analogue of natural amylin. Natural amylin is a pancreatic hormone that induces satiety. Cagrilintide's half-life was 159 to 195 hours, as established in research published by Enebo et al. in The Lancet in 2021.

Cagrilintide belongs to a different drug class than semaglutide, which is a glucagon-like peptide-1 (GLP-1) analogue. For additional context on how the GLP-1 component works alone, review our guide to Wegovy benefits.

Phase 2 Weight-Loss Results

Clinical evidence evaluating cagrilintide monotherapy comes primarily from a randomized phase 2 dose-finding trial published by Lau et al. in The Lancet in 2021. The 26-week study evaluated 706 adults without diabetes who had a body mass index (BMI) of at least 30 kg/m2, or at least 27 kg/m2 in the presence of hypertension or dyslipidaemia. Participants were randomized to receive once-weekly subcutaneous cagrilintide across five doses (0.3 mg, 0.6 mg, 1.2 mg, 2.4 mg, or 4.5 mg, with approximately 100 participants per group), daily subcutaneous liraglutide 3.0 mg (99 participants), or placebo (101 participants).

Weight reduction ranged from 6.0% to 10.8% across the evaluated cagrilintide cohorts under the trial product estimand, which assumes adherence.

Under the trial product estimand, participants assigned to cagrilintide 4.5 mg achieved a mean weight reduction of 10.8%, which was higher than the 9.0% reduction with daily liraglutide 3.0 mg (difference 1.8%, p=0.03). The treatment policy estimand gave similar results. The study was funded by Novo Nordisk.

Safety Profile and Adverse Events in Trials

Gastrointestinal symptoms represent the most common adverse events documented in clinical investigations of cagrilintide. In the phase 2 trial by Lau et al., adverse events affecting the digestive tract occurred in 41% to 63% of participants across the cagrilintide dose groups, compared to 32% of participants in the placebo group. Administration-site reactions were also documented among participants receiving the study drug.

Nausea was among the documented gastrointestinal symptoms during the phase 2 study. Reported rates of nausea ranged from 20% to 47% among cagrilintide-treated participants, compared to 18% in the placebo cohort. Permanent treatment discontinuation occurred in 10% of participants across the study arms, with 4% of participants stopping therapy specifically due to adverse events.

In a 20-week phase 1b safety study published by Enebo et al. in The Lancet in 2021, investigators evaluated 96 adults aged 18 to 55. Participants had a BMI between 27.0 and 39.9 kg/m2 at a single clinical centre in the United States. Participants were randomised to once-weekly cagrilintide (0.16 mg to 4.5 mg) or placebo, each combined with semaglutide 2.4 mg weekly. Gastrointestinal reactions accounted for 37% of the 566 total adverse events reported during the study. Most events were mild or moderate. At week 20, mean body weight reductions reached 15.7% with cagrilintide 1.2 mg plus semaglutide 2.4 mg, and 17.1% with cagrilintide 2.4 mg plus semaglutide 2.4 mg, compared to 9.8% in pooled placebo cohorts receiving semaglutide 2.4 mg alone. The authors concluded that the co-administration protocol was well tolerated.

In the larger 68-week phase 3a REDEFINE 1 trial published in the New England Journal of Medicine, gastrointestinal adverse events occurred in 79.6% of participants assigned to the fixed-dose CagriSema combination, compared to 39.9% assigned to placebo. Investigators reported that these gastrointestinal events were predominantly transient and mild to moderate in intensity.

Role Inside the CagriSema Combination

Cagrilintide has been studied mainly alongside semaglutide in the fixed-dose co-formulation CagriSema. In this formulation, cagrilintide 2.4 mg is combined with semaglutide 2.4 mg in one weekly injection. See what is CagriSema.

The phase 3a trial for this combination was the REDEFINE 1 study, published in the New England Journal of Medicine in 2025. The 68-week trial enrolled 3,417 adults with overweight or obesity and no diabetes. Participants were randomized in a 21:3:3:7 ratio across four parallel treatment groups: CagriSema (cagrilintide 2.4 mg plus semaglutide 2.4 mg), semaglutide 2.4 mg alone, cagrilintide 2.4 mg alone (302 participants), and placebo, all paired with lifestyle interventions.

Under the treatment-policy estimand, participants assigned to the CagriSema combination achieved an average body weight reduction of 20.4% at week 68, compared to 3.0% for participants in the placebo group. For the weight loss in the 302 participants in the cagrilintide 2.4 mg arm, check the NEJM study. For comparisons, see CagriSema vs Wegovy and CagriSema vs Zepbound.

What Is Still Unknown

No commercial price, label or dosing guidance exists for cagrilintide.

For comparisons, see CagriSema vs Retatrutide. For background on GLP-3, see what is GLP-3.

Next Steps for Patients

Patients evaluating pharmacological weight-loss options should discuss approved therapies with a licensed clinician.