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Human researchNot FDA-approved

Cagrilintide

Long-acting amylin analog

Also indexed as: Long-acting amylin analog

What this evidence does not tell us

The cited dose-finding phase 2 trial does not establish approval or suitability for an individual.

Terms on this page

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9 glossary terms used in this profile

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Definitions explain the words—not whether a molecule works or is safe. Research education only, not medical advice.

Overview

Cagrilintide is a long-acting peptide analog of amylin, a hormone normally released alongside insulin. It is an investigational metabolic agent.

Mechanism of action

Amylin signaling

An amylin analog that acts through amylin receptor complexes involved in satiety and gastric emptying.

A biological pathway describes a proposed or observed interaction—not necessarily a demonstrated health outcome.

Decode the terminology in our glossary

Scientific evidence

How strong is the evidence?

Human evidence is still developing

  1. Limited evidence
  2. Early research
  3. Human researchCurrent category
  4. Human outcomes

Studies in people exist, but the findings may be small, narrow, mixed or still need confirmation. A hormone or cell marker is not necessarily a health benefit.

For this research: The cited dose-finding phase 2 trial does not establish approval or suitability for an individual.

An editorial guide—not a validated score, a percentage, a safety rating or an approval badge. Regulatory status is separate. More research does not mean fewer risks.

Cell studies

Mechanistic laboratory evidence is not separately assessed in this selected-source summary; see references and their study types.

Animal experiments

Animal evidence is not separately assessed here. Findings in animals must not be interpreted as demonstrated human benefit.

Human observational studies

Associations, biomarker studies and anecdotes cannot establish treatment causality; no observational result is used here to infer clinical effectiveness.

Human clinical trials

The cited phase 2 randomized dose-finding trial studied weight outcomes in adults with overweight or obesity.

Regulatory evidence

No FDA-approved finished drug for this molecule is identified in this edition. Investigational use, published research or compounding does not establish FDA approval.

Potential research applications

Appetite regulation and body-weight outcomes in controlled studies.

These describe scientific questions, not prescribing recommendations. A research grouping does not establish combination safety or clinical effectiveness.

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Safety considerations

Nausea and other gastrointestinal effects occur in trials. Long-term safety and interactions outside studied protocols remain uncertain.

This is not an exhaustive safety or contraindication list. An absence of reported harm is not proof of safety. Pregnancy, breastfeeding, cancer history, endocrine disease and concurrent medicines can materially change risk. Unregulated preparations add identity, contamination and sterility risks.

Regulatory status · United States

Not FDA-approved

No FDA-approved finished drug for this molecule is identified in this edition. Investigational use, published research or compounding does not establish FDA approval.

Regulatory status and evidence strength are different. A nomination for compounding, a clinical-trial registration or a “research use only” label is not approval. International rules vary; consult the current regulator and product label.

Selected literature & source transparency

Clinical trial· 2021

Once-weekly cagrilintide for weight management in people with overweight and obesity: a multicentre, randomised, double-blind, placebo-controlled and active-controlled, dose-finding phase 2 trial.

Lancet (London, England)

Matched bibliographic records confirm a publication’s identity, not the validity of every claim. Selected sources are not a systematic literature review.

Continue your own source search

These open search results, not additional verified citations. Trial registration is not evidence that a treatment works.

Three questions worth bringing to your clinician

  1. Which human outcomes—not just biomarkers—support this claim?
  2. What established options address my actual health concern?
  3. What do my medical history and current medicines change about the risks?

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Education, not a prescription. Research summaries are not medical advice, dosing instructions, or an offer to sell. Mechanistic findings do not establish clinical effectiveness. US regulatory status is product- and indication-specific and may change. Discuss health decisions with a licensed clinician.