Cagrilintide Clinical Trials: What Phase 2, Phase 3, and FDA Status Show

Cagrilintide clinical trials have shown that the investigational amylin analog produces meaningful weight loss both alone and in combination with semaglutide. The most advanced combination, known as CagriSema, is in phase 3 testing under the REDEFINE program. Cagrilintide is not FDA-approved for any use, so it remains available only to clinical trial participants.

How Cagrilintide Works and Why It Is Being Studied

Cagrilintide is a long-acting analog of amylin, a hormone that the pancreas releases alongside insulin. Amylin helps regulate appetite, gastric emptying, and blood sugar. By mimicking amylin, cagrilintide may reduce food intake and improve glycemic control.

Novo Nordisk is developing cagrilintide as both a standalone treatment and as a combination with semaglutide. The combination, called CagriSema, pairs two appetite-suppressing hormones in one weekly injection. Researchers hope the dual mechanism will produce greater weight loss than either drug alone.

Cagrilintide Phase 2 Trials: Monotherapy and CagriSema Results

A key cagrilintide phase 2 trial tested cagrilintide monotherapy in adults with overweight or obesity. Over 26 weeks, participants taking cagrilintide 2.4 mg lost about 9% more weight than those on placebo. The highest dose, 4.5 mg, produced up to 10.8% average weight loss. Those findings were published in The Lancet in 2021.

A separate cagrilintide nejm publication reported the phase 2 results for CagriSema. In that 32-week trial, cagrilintide 2.4 mg plus semaglutide 2.4 mg led to an average weight loss of 17.1%. Cagrilintide alone produced 9.8% weight loss, and semaglutide alone produced 5.1%. The study appeared in the New England Journal of Medicine in 2022.

Trial	Treatment	Duration	Average weight loss
Phase 2 monotherapy	Cagrilintide 2.4 mg	26 weeks	~9%
Phase 2 monotherapy	Cagrilintide 4.5 mg	26 weeks	10.8%
Phase 2 CagriSema (NEJM)	Cagrilintide 2.4 mg + semaglutide 2.4 mg	32 weeks	17.1%
Phase 3 REDEFINE-1	CagriSema	68 weeks	22.7%

Cagrilintide Phase 3 Trials: The REDEFINE Program

Novo Nordisk launched the cagrilintide phase 3 program, known as REDEFINE, to confirm the phase 2 findings in larger, longer studies. REDEFINE-1, the main obesity trial, reported in December 2024 that CagriSema produced 22.7% weight loss at 68 weeks. That result was strong but fell short of the company's 25% target.

REDEFINE-2 tested CagriSema in adults with type 2 diabetes. In February 2025, Novo Nordisk reported that the combination reduced HbA1c by 1.55 percentage points. Additional cagrilintide trial arms are studying cardiovascular outcomes, sleep apnea, and other conditions.

Cagrilintide FDA Approval Status

As of 2025, cagrilintide fda approval has not been granted. Cagrilintide is an investigational drug, and the FDA has not approved it for weight loss or any other indication. Novo Nordisk has said it plans to submit a regulatory application for CagriSema, likely in 2026.

Until the FDA reviews that application, cagrilintide is only legally available through clinical trials. That means no pharmacy can sell it, and no telehealth service can prescribe it. Patients should be cautious of any website claiming to sell cagrilintide.

How Cagrilintide Compares to Tirzepatide and Retatrutide

A cagrilintide vs tirzepatide comparison is a common search because both drugs produce large weight loss, but they work differently. Tirzepatide is a dual GIP/GLP-1 agonist approved as Zepbound and Mounjaro. Cagrilintide is an amylin analog and is not approved. A cagrilintide vs retatrutide vs tirzepatide comparison is difficult because no head-to-head trials have been published.

Separately, clinical trials retatrutide have reported up to 24.2% weight loss at 48 weeks in a phase 2 study. Retatrutide is a triple agonist targeting GIP, GLP-1, and glucagon. That mechanism is different from cagrilintide, which targets amylin.

Drug	Mechanism	FDA status	Average weight loss in trials
Cagrilintide (as CagriSema)	Amylin analog + GLP-1 agonist	Investigational	22.7% at 68 weeks
Tirzepatide	GIP/GLP-1 dual agonist	Approved	20.9–22.5% at 72 weeks
Retatrutide	GIP/GLP-1/glucagon triple agonist	Investigational	Up to 24.2% at 48 weeks

Cagrilintide Dosage, Safety, and Side Effects

In clinical trials, cagrilintide dosage has ranged from 0.3 mg to 4.5 mg once weekly. The most common side effects are gastrointestinal: nausea, vomiting, diarrhea, and constipation. These side effects usually lessen as the body adjusts. Because cagrilintide is investigational, no established safe dosage exists outside a trial setting.

Other amylin analogs are also in development. For a comparison, see eloralintide vs cagrilintide. Anyone considering cagrilintide should consult a healthcare professional and avoid unregulated sources. The FDA has warned that compounded or research-grade cagrilintide is not the same as the investigational product used in trials.

The Bottom Line

Cagrilintide clinical trials have established the drug as a promising appetite suppressant, especially when combined with semaglutide. Phase 2 results showed 10.8% weight loss for monotherapy and 17.1% for CagriSema. Phase 3 REDEFINE-1 showed 22.7% weight loss at 68 weeks.

Cagrilintide is not FDA-approved. Approval may depend on the upcoming CagriSema submission and further phase 3 data. For now, cagrilintide remains an investigational option available only through clinical trials.

COMMON QUESTIONS

Frequently Asked Questions

Is cagrilintide FDA approved?

No. As of 2025, the FDA has not approved cagrilintide for weight loss or any other condition. It remains an investigational drug available only through clinical trials. Novo Nordisk may submit CagriSema for approval in 2026.

What did the phase 3 trials show for cagrilintide?

The REDEFINE-1 phase 3 trial showed that CagriSema, which contains cagrilintide plus semaglutide, produced 22.7% average weight loss at 68 weeks. REDEFINE-2 showed a 1.55 percentage point reduction in HbA1c in people with type 2 diabetes. These results are not yet reviewed by the FDA.

Can I get cagrilintide now?

Cagrilintide is not commercially available. The only legal way to get it is by joining a clinical trial. Websites selling cagrilintide are unregulated and may be unsafe. Talk to a healthcare professional about approved weight loss options.