Skip to content
Peptide Evidence Registry

GLP-1s & incretins

Cagrilintide

A long-acting amylin analogue, now in its own Phase 3 programme as well as in combination therapy.

L4Good human trialsIn clinical trialsIn clinical development
How settled this rating is:
moderate confidence in the current evidence rating
Routes studied:
Subcutaneous injection
Also known as:
amylin analogue, component of combination therapy
Last reviewed:
2026-09-08
Jump to section

Evidence passport

Cagrilintide

A one-screen evidence identity for this compound. These fields describe research maturity, confidence and legal status. They are not a safety guarantee, efficacy percentage or recommendation.

Reviewed 2026-09-08
Evidence level
L4Good human trials
Confidence
Moderate confidence in rating
Regulatory status
In clinical trials
Development status
In clinical development

Evidence strength

Human efficacy evidence68 of 100 evidence strength

Higher = more and better-quality human evidence. It does not mean the effect is bigger or that the compound works for you.

Human safety evidence45 of 100 evidence strength

Higher = more mature, better-documented human safety data. It does not mean the compound is safer than one with a lower number.

The 0-100 values rate the strength and maturity of evidence, not how effective or safe the compound is.

Evidence base
Includes human studies
Furthest established stage
Phase III
Human research maturity
Phase 3 (RENEW) as monotherapy; also studied within a fixed-dose combination
Source curation
Sources fully curated

Routes recorded

SC injection

Evidence Diff

What changed since the previous recorded review?

Grade unchanged

Previous recorded review

L4

Latest recorded review

L4

Latest material update

Standalone cagrilintide has entered the RENEW Phase 3 programme. The REDEFINE-1 cagrilintide arm showed about 11.8% mean weight loss versus 2.3% with placebo at 68 weeks under the adherence estimand.

Amylin pharmacology now has a standalone late-stage test rather than existing mainly as a combination partner. CagriSema, the fixed-dose combination with semaglutide, is tracked separately as a GLP-1 Centre pipeline entry — combination results do not transfer to either component alone.

This comparison uses only recorded change-log fields. Historical confidence is not inferred when it was not explicitly stored. A grade change still requires human editorial review.

Overview

Human efficacy evidence strength68 of 100 evidence strength

Higher = more and better-quality human evidence. It does not mean the effect is bigger or that the compound works for you.

Preclinical (animal / lab) evidence strength78 of 100 evidence strength

Higher = more animal, tissue or cell research. Preclinical results are a starting point, not proof of a human benefit.

Human safety evidence strength45 of 100 evidence strength

Higher = more mature, better-documented human safety data. It does not mean the compound is safer than one with a lower number.

How to read these scores

Every number here rates the evidence, not the compound. They are editorial 0-100 strength ratings, not percentages, and not a rating out of five stars.

  • Human efficacy evidence strength — Higher = more and better-quality human evidence. It does not mean the effect is bigger or that the compound works for you.
  • Preclinical evidence strength — Higher = more animal, tissue or cell research. Preclinical results are a starting point, not proof of a human benefit.
  • Human safety evidence strength — Higher = more mature, better-documented human safety data. It does not mean the compound is safer than one with a lower number. A score of 80 does not mean “80% safe”.
  • Evidence level (L0-L5) — the strongest type of study behind the compound, from anecdote (L0) to large replicated human trials (L5). It is a description of the study evidence, not a quality, safety or recommendation rating.
  • Confidence — how likely we think it is that this rating changes as new research lands. Low confidence means the picture is unsettled, not that the compound is bad.

None of these ratings is medical advice, a safety guarantee, or a recommendation to use anything. How we grade evidence.

How far human research has progressed: Phase 3 (RENEW) as monotherapy; also studied within a fixed-dose combination

Routes & formulations

Studied / approved routes

SC injection

Clinical trials use subcutaneous injection; there is no approved formulation of any kind.

Route availability is not evidence of efficacy, and evidence from one route does not transfer to another. The Registry never provides dosing or sourcing information.

Peptide lifecycle

  1. Discovery

  2. Preclinical

  3. Phase I

  4. Phase II

  5. Phase III

    Furthest established stage

  6. Approved

In clinical development

Active development on two separate tracks: standalone cagrilintide in the RENEW Phase 3 programme, and the CagriSema fixed-dose combination, which is covered as a pipeline entry in the GLP-1 Centre rather than as a peptide profile.

Last documented development: 2026 — standalone RENEW Phase 3 programme

What it is

A synthetic long-acting version of amylin, a hormone co-secreted with insulin that promotes satiety and slows gastric emptying through a different route from GLP-1.

What people claim

  • Adds weight loss on top of GLP-1 therapy
  • Different satiety pathway, additive effect

What the evidence actually says

Amylin pharmacology on its own now has a real Phase 3 test. In REDEFINE-1 the cagrilintide arm showed roughly 11.8% mean weight loss versus 2.3% on placebo at 68 weeks under the adherence estimand — a genuine standalone effect, though smaller than the incretin medicines it is often compared with. Long-term safety and any regulatory decision remain open.

Related evidence

Useful next reads based on this compound — not recommendations.

Human evidence

  • REDEFINE-1 cagrilintide arm: about 11.8% mean weight loss versus 2.3% with placebo at 68 weeks (adherence estimand).
  • Standalone RENEW Phase 3 programme under way.
  • Randomised combination trials showing additive weight reduction versus GLP-1 therapy alone.

Preclinical evidence

  • Amylin receptor pharmacology and rodent satiety models.

Animal and cell findings are Level 1–2 evidence.

Mechanism and pathways

  • Amylin/calcitonin receptor signalling in the area postrema reduces meal size.
  • Complementary rather than duplicative to GLP-1 signalling.

Safety and unknowns

  • Gastrointestinal effects, injection-site reactions.
  • Long-term safety of chronic amylin agonism remains under study.

Cancer relevance

This section covers questions raised by how the compound works in the body, plus anything regulators and trial teams keep an eye on. It is not a statement that this compound causes cancer — for most compounds here, no human data exist in either direction.

No established human signal

No established human cancer signal. Not a primary safety question for this compound.

Regulatory status

Regulatory decisions apply to specific jurisdictions, products, formulations and indications. An approval elsewhere is not automatically an approval in your country.

Check the regulatory note and linked primary sources for jurisdiction-specific details.

Investigational and not approved anywhere. Standalone cagrilintide has entered the RENEW Phase 3 programme. It is also one half of CagriSema, a separate fixed-dose combination with semaglutide — the combination has its own trials and its own regulatory filing, and results do not transfer between them. FDA states explicitly that cagrilintide cannot be used in compounding under US federal law, because it is not an FDA-approved drug and is not on a bulk drug substances list permitted for compounding. That is a compounding and legal-status point about US supply routes — it is not a finding about how well cagrilintide works, and not a new intrinsic-toxicity finding about the molecule.

Evidence grade

L4Good human trialsModerate confidence in rating

Completed, adequately informative controlled human trials supporting a specified outcome; replication and longer-term safety may remain uncertain.

What would change our rating?

  • RENEW Phase 3 monotherapy readouts, peer-reviewed.
  • A regulatory decision on either the monotherapy or the combination.

References and sources

Source transparency

A provenance snapshot of this profile. Counts show what kinds of sources are cited, not how much scientific weight each source deserves.

Sources fully curated
Last editorial review
2026-09-08
Recently reviewed · 38 days ago
Linked curated sources
2
Sources still pending
0
External specialist reviews
0
None recorded for this profile
Regulatory / label: 1Sponsor / official: 1

Review provenance

Registry editorial review: Colin Jackson-White, creator and editor, who is not a doctor or clinician. External specialist review is credited only when a named reviewer has completed a review of this exact profile.

Literature-discovery and AI tools may help locate or challenge candidate evidence, but they are not counted as evidence sources here. Registry judgements are tied to the underlying papers, trial records, regulator documents and official study records.

Source hierarchy: regulatory documents and trial registries first, peer-reviewed work next, sponsor material flagged as non-independent. We never use supplier or clinic marketing as evidence, and where a verified source has not yet been curated we say so rather than inventing one.

Evidence change history

These entries record changes to our assessment of the published evidence — not changes to the compound itself.

  1. Standalone cagrilintide has entered the RENEW Phase 3 programme. The REDEFINE-1 cagrilintide arm showed about 11.8% mean weight loss versus 2.3% with placebo at 68 weeks under the adherence estimand.

    Change 1 of 2
    L4Good human trials
    Amylin pharmacology now has a standalone late-stage test rather than existing mainly as a combination partner. CagriSema, the fixed-dose combination with semaglutide, is tracked separately as a GLP-1 Centre pipeline entry — combination results do not transfer to either component alone.

  2. Baseline entry: added as combination-therapy candidate with moderate confidence.

    Change 2 of 2
    L4Good human trialsBaseline entry
    Additive weight reduction in combination trials is supported. Standalone long-term evidence remains limited.