Cagrilintide peptide: Phase 3 trials, results, side effects, and FDA status.
Also searched as AM833 · NNC0174-0833
Cagrilintide is Novo Nordisk’s investigational long-acting amylin analogue. It is both the amylin component of CagriSema and a standalone once-weekly weight-management program, which makes “cagrilintide” and “CagriSema” related but non-interchangeable search topics.
Is cagrilintide in Phase 3?
Yes. Novo Nordisk says standalone cagrilintide entered the RENEW Phase 3 program after the monotherapy findings from REDEFINE 1. RENEW 1 studies adults with overweight or obesity, while RENEW 2 studies a population with type 2 diabetes. Both records are active Phase 3 studies with no posted results at this check. Phase 3 status means the evidence program is advanced; it does not mean the drug is FDA approved or available from legitimate retail pharmacies.
Compare Cagrilintide with CagriSema, without losing the country context.
Put evidence status, ClinicalTrials.gov coverage, official United States records, and qualified US research prices in one view. Blank fields stay blank when the underlying dataset does not support a number.
Investigational clinical program
Official product and seller records attached
Investigational clinical program
What can you conclude about Cagrilintide today?
These are dated program facts, not a cross-trial ranking, approval forecast, personal treatment recommendation, or proof that a same-name online product is the sponsor's medicine.
Designed for prolonged activity and once-weekly subcutaneous dosing.
Mean loss versus 2.3% with placebo if all participants adhered to treatment.
Phase 3 records cover obesity with and without type 2 diabetes and have no posted results yet.
CagriSema combines cagrilintide with semaglutide; it is not the same product as cagrilintide alone.
Know which molecule the result belongs to.
- Sponsor
- Novo Nordisk
- Mechanism
- Long-acting amylin analogue
- Route being studied
- Once-weekly subcutaneous injection
- Current stage
- Phase 3 monotherapy program
- Featured trial anchors
- NCT03856047 · NCT05567796 · NCT07220642 · NCT07220759
- Evidence checked
- July 20, 2026
Cagrilintide weight-loss results, with the trial attached.
This visual shows one selected result, not every dose or endpoint in the program. The percentage remains attached to its duration, population, comparator, analysis method, and source.
Evidence checked July 21, 2026Cagrilintide reported 11.8% mean reduction at 68 weeks under the trial-product estimand. The comparator recorded 2.3% mean reduction.
Bar lengths share a 0 to 30% visual scale. They describe this selected record and do not make separate trials head-to-head.
- Population
- Adults with obesity or overweight and at least one complication
- Participants
- 3,417 Total randomized trial population; this row represents the cagrilintide arm
- Dose
- Cagrilintide 2.4 mg, flexible dosing
- Primary analysis
- Trial-product estimand
- Alternate analysis
- Treatment-policy estimand
- Regulatory status
- Investigational; not FDA approved
Cagrilintide clinical trials by status, phase, and location.
The current exact-intervention snapshot matches 52 unique NCT records. This chart describes registry coverage and current study fields. It does not compare efficacy, safety, approval probability, eligibility, or treatment access.
Snapshot 2026-07-24Counts use individual locations currently marked Recruiting, not every facility listed on an overall-recruiting study. Repeated centers across studies remain repeated site observations.
What comes after Retatrutide?
Compare Zenagamtide/Amycretin, MariTide, CagriSema, standalone cagrilintide, and survodutide by route, evidence maturity, trial result, and approval status without ranking unrelated studies as one race.
Open the upcoming weight-loss drugs guide →Cagrilintide across 42 countries.
This profile establishes the program identity and its cited clinical or regulatory record. It does not turn a same-name seller listing into the sponsor’s asset or prove authorization, availability, or lawful supply in another destination.
Compare Cagrilintide by country →Compare Cagrilintide by US state →Browse the global peptide country dataset →Is Cagrilintide approved or available in your country?
Start with the United States FDA record, then check the destination that matters to you. Each country page separates drug identity, authorization, product records, seller claims, and supply rules. Directory checked July 20, 2026.
What the record shows - and what it doesn’t.
Trial percentages are kept beside the design details that make them interpretable. Unknowns stay visible instead of being filled with launch speculation.
Standalone Phase 2 dose finding
A randomized Phase 2 trial assigned 706 participants to cagrilintide dose groups, 99 to liraglutide, and 101 to placebo for 26 weeks. Reported mean weight change ranged from 6.0% to 10.8% across cagrilintide groups versus 3.0% with placebo. Gastrointestinal events occurred in 41% to 63% of cagrilintide participants versus 32% with placebo, and nausea occurred in 20% to 47% versus 18%.
A Phase 3 monotherapy signal exists
In the cagrilintide arm of REDEFINE 1, Novo Nordisk reported 11.8% mean weight loss versus 2.3% with placebo at 68 weeks under the trial-product estimand. More than 30% achieved at least 15% loss, compared with less than 5% on placebo.
RENEW is the standalone program
Novo Nordisk’s 2025 annual report says cagrilintide entered the RENEW Phase 3 program. ClinicalTrials.gov lists RENEW 1 for adults with overweight or obesity and RENEW 2 for a population with type 2 diabetes. Both are randomized, placebo-controlled monotherapy trials with no posted results at this evidence check.
It is not an approved medicine
Cagrilintide monotherapy has no FDA-approved obesity label, dose, commercial price, pharmacy channel, or coverage policy. FDA says cagrilintide is not a component of an FDA-approved drug, has not been found safe and effective for any condition, and cannot be used in compounding under federal law.
Combination results do not transfer
The 22.7% REDEFINE 1 result belongs to CagriSema, not cagrilintide alone. Pages that attach the combination result to standalone cagrilintide blur two different interventions.
Phase 3 outcomes are still developing
RENEW trials must establish longer-term efficacy, safety, tolerability, and how the standalone program compares with available options. Early or subgroup findings cannot answer every commercial question.
The questions behind the search.
Concise answers based on the dated sponsor and trial records below. This is educational reporting, not medical advice.
What is cagrilintide?
Cagrilintide is an investigational, long-acting analogue of amylin, a hormone involved in satiety and meal-related signaling. Novo Nordisk is studying it as a once-weekly injection for weight management. It also supplies the amylin component of CagriSema, where it is combined with semaglutide. Because standalone cagrilintide and the fixed-dose combination contain different active regimens, their trial results and regulatory status should be tracked separately.
How is cagrilintide different from CagriSema?
Cagrilintide is one investigational molecule and acts as a long-acting amylin analogue. CagriSema is a fixed-dose combination containing cagrilintide plus semaglutide, a GLP-1 receptor agonist. In REDEFINE 1, the reported treatment-adherent mean weight loss was 11.8% for cagrilintide alone and 22.7% for the combination, each versus 2.3% with placebo. Those findings belong to separate randomized arms, not interchangeable names for one product.
Is cagrilintide in Phase 3?
Yes. Novo Nordisk says standalone cagrilintide entered the RENEW Phase 3 program after the monotherapy findings from REDEFINE 1. RENEW 1 studies adults with overweight or obesity, while RENEW 2 studies a population with type 2 diabetes. Both records are active Phase 3 studies with no posted results at this check. Phase 3 status means the evidence program is advanced; it does not mean the drug is FDA approved or available from legitimate retail pharmacies.
Can you buy cagrilintide, and what is its price?
There is no FDA-approved cagrilintide product, commercial list price, pharmacy inventory, insurance coverage policy, or approved prescription route to compare. FDA says cagrilintide cannot be used in compounding under federal law and warns consumers about products sold as cagrilintide outside clinical trials. A seller price for a same-name research vial is not the price of Novo Nordisk’s clinical program and does not authenticate its identity, quality, or safety.
What side effects were reported with cagrilintide?
In the 26-week Phase 2 dose-ranging trial, gastrointestinal adverse events were the most common. They occurred in 41% to 63% of cagrilintide participants across dose groups versus 32% with placebo, while nausea occurred in 20% to 47% versus 18%. Those are trial-group observations, not a final approved safety label. RENEW Phase 3 trials are intended to add longer and larger monotherapy evidence.
Do not use an investigational name, trial dose, or online research listing as a substitute for approved care. This page does not recommend treatment, sourcing, or participation in a clinical trial.
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