Cagrilintide: Published Trials and Regulatory Status

Read cagrilintide and CagriSema trial results, distinguish standalone and combination evidence, and check dated U.S. regulatory status and ongoing studies.

Inside Peptides Editorial Team5 min readUpdated 10 October 2026

Synthetic illustration of a clinical research coordinator reviewing trial documents beside a weighing scale, illustrating cagrilintide research without depicting an actual trial. — Synthetic editorial illustration. No actual experiment is shown.

Key takeaways

Cagrilintide is not FDA-approved at the dated U.S. check.
Combination effects must not be assigned to cagrilintide alone.
Published weight trials do not settle cardiovascular outcomes.

In this article

Cagrilintide has published human trial evidence, but it is not an FDA-approved medicine as of 10 October 2026. It is being studied alone and with semaglutide; the combination is often called CagriSema. Results for the combination must not be described as results for cagrilintide alone. FDA’s current statement says cagrilintide is not a component of an approved drug and cannot be used in compounding under U.S. federal law.¹

This article covers selected published trials and the United States regulatory position. It does not assume the same status in every country or provide a treatment regimen. For context, use the peptide library and clinical evidence center.

What cagrilintide is being designed to do

Cagrilintide is a long-acting amylin analogue: a modified molecule designed to mimic aspects of amylin, a pancreatic hormone involved in fullness after eating. Semaglutide activates GLP-1 receptors, a different signaling system. The combination tests whether these approaches can produce useful clinical outcomes together. Mechanism is a rationale for research, not proof of a particular benefit.²

Read our semaglutide research profile to understand why effects belong to a particular formulation, population and outcome.

What selected published trials show

The figures below describe study results, not instructions or expected individual weight loss. Percentage points express the difference between two percentages.

Trial / publication	Population and size	Duration	Selected published result	Important limit
Cagrilintide phase 2, 2021	706 randomized adults without diabetes, across cagrilintide, liraglutide and placebo groups	26 treatment weeks	Cagrilintide-arm mean weight reductions ranged from 6.0% to 10.8%, versus 3.0% with placebo, under the trial-product analysis	Dose-finding study; adherence-assuming analysis differs from an all-treatment-policy estimate²
REDEFINE 1, 2025	3,417 randomized adults without diabetes; four arms	68 weeks	Cagrilintide–semaglutide: −20.4%; placebo: −3.0%. Model-estimated difference −17.3 percentage points, 95% CI −18.1 to −16.6	Combination result, not cagrilintide-alone result³
REDEFINE 2, 2025	1,206 randomized adults with type 2 diabetes; 904 combination, 302 placebo	68 weeks	Combination: −13.7%; placebo: −3.4%. Model-estimated difference −10.4 percentage points, 95% CI −11.2 to −9.5	Different diabetes population; cannot compare percentages with REDEFINE 1 as if randomized between trials⁴
REDEFINE 5, 2026	331 randomized adults in Japan/Taiwan; 164 combination, 167 semaglutide	68 weeks	Combination: −18.4%; semaglutide: −11.9%. Estimated difference −6.5 percentage points, 95% CI −8.4 to −4.6	Selected regional eligibility; trial-product analysis assumes treatment as intended⁵

REDEFINE 1 included 302 participants in a cagrilintide-alone arm, alongside the other groups. The −20.4% figure belongs to the 2,108-person combination arm. It must not be assigned to the standalone ingredient. Model-estimated differences need not equal subtraction of rounded displayed means.³

These are selected trials, not an exhaustive inventory. All four reports identify Novo Nordisk funding. Sponsorship does not invalidate a result; it makes checking prespecified outcomes, missing data, reporting and replication especially useful.^2,3,4,5

Why different analysis assumptions matter

A treatment-policy estimate aims to reflect assignment regardless of discontinuation or other specified events. A trial-product estimate asks a question assuming treatment is taken as intended. These can produce different numbers from the same trial. Neither should be relabeled without explaining the question it answers.

Before sharing a percentage, check the table footnote and supplement. Our guide to clinical trial results tables explains this distinction.

Completed results and ongoing outcome research are different

REDEFINE 1 has a published primary report and its official registry record, NCT05567796, identifies the study. Publication is evidence of a reported trial; registry information helps check what was planned.^3,6

The official record for REDEFINE 3, NCT05669755, was active, not recruiting, with no posted registry results at the 10 October 2026 check. It studies cardiovascular outcomes in people with heart and blood-vessel disease. A weight-loss result does not establish fewer cardiovascular events for this combination; that requires the appropriate outcome data. Registry status is sponsor-reported and can change.⁷

Safety findings and remaining uncertainty

Read adverse events, serious events and withdrawals alongside weight outcomes. Gastrointestinal tolerability is important in this research program. A selected efficacy table is not a full harm assessment, and a study conclusion describing tolerability does not establish risk for every patient or prolonged exposure.^2,3,4,5

Research material under a trial protocol is also different from an online vial bearing the same name. Published trials do not verify the identity, quality or safety of an unrelated commercial preparation. Read approved versus unapproved peptide products and clinical safety reporting.

What this means for readers

The evidence supports describing cagrilintide and CagriSema as compounds with substantial clinical development and measurable trial outcomes. It does not support calling cagrilintide FDA-approved, presenting combination outcomes as standalone effects, or promising an individual result. Regulatory approval, clinical efficacy and commercial product quality are separate questions.