Cagrilintide and CagriSema: Trial Results and FDA Status (2026)

Cagrilintide is a long-acting version of amylin, a pancreatic hormone that helps you feel full. CagriSema pairs 2.4 mg of it with 2.4 mg of semaglutide in a weekly shot. Neither is FDA-approved. Novo Nordisk filed CagriSema in December 2025 and expects a decision in the fourth quarter of 2026. Cagrilintide sold on its own is an unapproved drug.

The interest is easy to understand. In its main obesity trial, CagriSema produced about 20% average weight loss over 68 weeks. And peptide sellers are already marketing "cagrilintide microdoses" to people who would rather not wait. Here is what the trials actually tested, and what that means for anyone tempted by a vial today.

What is amylin, and why pair it with semaglutide?

Amylin is a hormone made in the pancreas that induces satiety, the sense of having eaten enough. Cagrilintide is a long-acting analog of it, built to be injected once a week ¹.

Semaglutide works on a different receptor, GLP-1. Novo describes the combination as targeting two complementary pathways at once ⁴. The bet behind CagriSema is simple: two fullness signals should do more than one.

What did cagrilintide do on its own?

The first serious test was a 26-week phase 2 dose-finding trial in 706 adults on cagrilintide alone, at 0.3, 0.6, 1.2, 2.4 or 4.5 mg once a week ¹. Every dose beat placebo. Average weight loss across the cagrilintide groups ran from 6.0% to 10.8%, against 3.0% on placebo, and the top dose edged out daily liraglutide 3.0 mg (10.8% vs 9.0%) ¹.

For a low-dose reader, that trial is the interesting one. It tested doses down to 0.3 mg and still found a measurable effect at the bottom of the range. It also found the familiar side-effect pattern: gastrointestinal events in 41% to 63% of people on cagrilintide versus 32% on placebo, mostly nausea ¹. That was a 26-week trial of a drug that has never been approved at any dose, so it settles nothing about using cagrilintide outside a study.

The 2.4 mg dose is the one Novo carried forward into CagriSema.

What did CagriSema do in phase 3?

REDEFINE 1 enrolled 3,417 adults with obesity, or overweight plus a related condition, and no diabetes. After 68 weeks, average weight loss was 20.4% on CagriSema against 3.0% on placebo, counting everyone randomized ². Novo's estimate for people who stayed on treatment was 22.7% ⁴. The trial also included smaller cagrilintide-only and semaglutide-only groups, each at 2.4 mg ².

REDEFINE 2 enrolled 1,206 adults with type 2 diabetes. Weight loss was 13.7% versus 3.4% on placebo, and 73.5% of people on CagriSema reached an HbA1c of 6.5% or lower, against 15.9% on placebo ³. As with every drug in this class, people with diabetes lost less.

REDEFINE 4 was the one Novo didn't want to lose. It put CagriSema against tirzepatide 15 mg for 84 weeks in 809 people. CagriSema produced 23.0% weight loss versus 25.5% for tirzepatide among people who stayed on treatment, and 20.2% versus 23.6% counting everyone. The trial missed its primary goal of showing CagriSema was not worse than tirzepatide ⁵.

How common were side effects?

Mostly gastrointestinal, and more common than on placebo by a wide margin. In REDEFINE 1, 79.6% of people on CagriSema reported a gastrointestinal event, versus 39.9% on placebo; nausea hit 55% (12.6% on placebo), constipation 30.7% (11.6%) and vomiting 26.1% (4.1%) ⁴. In REDEFINE 2 the gastrointestinal figure was 72.5% versus 34.4% ³.

Fewer people quit than those numbers might suggest. Stopping because of side effects was 5.9% on CagriSema versus 3.5% on placebo in REDEFINE 1, and 8.4% versus 3% in REDEFINE 2 ⁴.

Is CagriSema approved yet?

Not as of October 2, 2026. Novo submitted a New Drug Application on December 18, 2025, for weight reduction and long-term maintenance in adults with obesity, or overweight plus at least one weight-related condition ⁴. In its September 30, 2026 release the company still described CagriSema as investigational and said a decision is expected in the fourth quarter of 2026 ⁶.

Two more things are coming. Novo started a phase 3 trial in 2026 of a higher-dose version, cagrilintide 2.4 mg with semaglutide 7.2 mg ⁶, and its REDEFINE 11 trial of the current dose is expected to report in the first half of 2027 ⁵.

Is "cagrilintide microdosing" safe or legal?

The FDA is direct about this. Cagrilintide cannot be used in compounding under federal law, is not a component of any FDA-approved drug, and has not been found safe and effective for any condition ⁷. That rules out a legitimate compounded version, which leaves gray-market vials.

The agency has already acted on them. In a March 2026 warning letter, it told a website selling "Cagrilintide" vials labeled for laboratory research that the products were unapproved new drugs intended for human use ⁸. In December 2025 it cited an ingredient distributor for supplying cagrilintide acetate to compounders, among other substances it called ineligible for compounding ⁹.

So a cagrilintide "microdose" is an unapproved drug at an untested schedule, from a source nobody has inspected. The phase 2 doses in the table above were Novo's own product at verified strengths. A vial bought online has no such guarantee, and the risks of unregulated GLP-1-type products apply in full.

What can you take now?

If CagriSema's appeal is a lower-intensity way into the class, the approved drugs already start low. Semaglutide itself, the other half of CagriSema, begins at 0.25 mg a week as Wegovy; why people try to stay near that end, and what the evidence says, is in microdosing Wegovy. For the bigger picture of how weight loss scales with dose across the class, see GLP-1 dose-response.

Novo says that, if approved, CagriSema would be the first injectable combination of a GLP-1 drug and an amylin analog ⁴. Until the FDA rules, it exists only in trials.