Novo Nordisk starts recruiting phase 3 trial of two cagrilintide injection versions
Novo Nordisk is recruiting a phase 3 trial of two injectable cagrilintide versions in people with excess weight; the drug showed 11.8% average weight loss in earlier phase 3 data.
Novo Nordisk has begun recruiting for a phase 3 study that compares two different injectable presentations of cagrilintide with placebo in people with excess body weight. The trial moved from "not yet recruiting" to "recruiting" [1]. Cagrilintide is not approved for any use; it is an investigational long-acting amylin analog given once a week as a subcutaneous injection [2].
What distinguishes the two injectable presentations has not been disclosed, and neither have the number of participants, the doses being tested, the length of the study or when results might be available.
The only phase 3 data reported so far for cagrilintide as a standalone treatment come from a sub-analysis of the REDEFINE 1 trial, presented at the European Association for the Study of Diabetes congress in Vienna in September 2025 [2]. That analysis looked at adults with obesity or overweight plus at least one weight-related condition, and without type 2 diabetes. Average weight loss was 11.8% with cagrilintide 2.4 mg versus 2.3% with placebo over 68 weeks when counting only participants who stayed on treatment [2]. Counting everyone regardless of adherence, the averages were 11.5% and 3.0% [2].
About 31.6% of participants taking cagrilintide lost at least 15% of their body weight, compared with 4.7% on placebo, under the adherence-based measure; the figures were 31.0% and 5.2% under the measure that counts all participants [2].
The most common side effects were gastrointestinal, including nausea, vomiting, diarrhea and constipation, and were mainly temporary and mild to moderate, according to the company [2]. Nausea led 1.0% of participants on cagrilintide to stop treatment permanently, compared with 0.1% on placebo [2].
"Like other chronic diseases, we need a range of treatment options to address the individual needs of people with obesity, such as their own specific response to treatment," lead investigator Timothy Garvey, MD, of the University of Alabama at Birmingham, said in the announcement [2]. Martin Holst Lange, Novo Nordisk's chief scientific officer, said the company looked forward to "further investigating cagrilintide's potential in the dedicated phase 3 RENEW programme" [2].
The REDEFINE 1 numbers come from a post hoc sub-analysis rather than a trial designed specifically to test cagrilintide alone, and results from different trials are not directly comparable because the study groups and methods differ.
Why it matters for patients
Cagrilintide copies amylin, a hormone the body makes naturally, and the company says it works differently from currently approved GLP-1-based weight-loss treatments such as semaglutide (Ozempic, Wegovy, Rybelsus) and tirzepatide (Mounjaro, Zepbound) [2]. That means it could eventually become an option for people who do not respond well to, or cannot tolerate, GLP-1 medicines — but only if phase 3 trials confirm the benefit and the Food and Drug Administration approves it. No approval has been sought or granted so far.
If two injectable presentations are eventually marketed, the difference could matter in practical ways, such as how a device is handled or how a dose is delivered. No details on those differences have been reported, so it is too early to say whether one would suit any particular patient better. Nothing about this trial changes the status of any medicine people take today, and the study is enrolling a specific population defined by the researchers [1].
What happens next
Novo Nordisk said the dedicated phase 3 RENEW program for cagrilintide was due to start in the fourth quarter of 2025, with cagrilintide dosed at 2.4 mg once weekly [2]. It has not been reported whether the newly recruiting study is part of RENEW.
Separately, CagriSema — a combination of cagrilintide and semaglutide — is also in phase 3 testing. A phase 3 study of CagriSema in children and adolescents with type 2 diabetes moved to recruiting on September 9, 2026, and a new phase 3 study of switching from semaglutide to CagriSema, with 210 planned participants, was registered [1]. A phase 2 study of CagriSema in people with type 2 diabetes and painful diabetic peripheral neuropathy has been completed [1].
Completion dates and result announcements for the two-presentation cagrilintide study have not been disclosed.
Sources
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