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GLP-1s & incretins · Metabolic & endocrine · Neuro & cognitive

Brenipatide

An investigational dual GIP and GLP-1 receptor agonist now in Phase 3 trials for alcohol use disorder and major depressive disorder, with no efficacy results published.

L1Theory onlyIn clinical trialsIn clinical development
How settled this rating is:
very-low confidence in the current evidence rating
Routes studied:
Subcutaneous injection
Also known as:
LY3537031, GIP/GLP-1 dual receptor agonist
Last reviewed:
2026-09-11
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Evidence passport

Last reviewed 2026-09-11

A one-screen summary of what is known about this compound. Every field describes the evidence and legal status — not how safe or effective it is, and not a recommendation. The 0-100 figures are evidence-strength ratings, not percentages.

Evidence level (type of study, not a quality rating)
L1Theory only
How settled this rating is
Very low confidence in rating
Human efficacy evidence
12 of 100 evidence strength
Human safety evidence
8 of 100 evidence strength
Regulatory status
In clinical trials
Development
In clinical development
Routes
SC injection
Evidence base
Includes human studies
Furthest stage
Phase III
Source curation
Sources fully curated
How far human research has progressed
Two Phase 3 trials in alcohol use disorder recruiting since October 2025 (estimated primary completion April 2028); no Phase 3 results posted, and no earlier-phase results are established in our curated record

Overview

Human efficacy evidence strength12 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 strength45 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 strength8 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: Two Phase 3 trials in alcohol use disorder recruiting since October 2025 (estimated primary completion April 2028); no Phase 3 results posted, and no earlier-phase results are established in our curated record

Routes & formulations

Studied / approved routes

SC injection

Our curated record establishes the development programme and receptor targets, not a final formulation or administration schedule. Anything sold under this name outside a registered trial is unapproved material of unverified identity.

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. Reaching Phase 3 means earlier-phase work exists, but our curated record contains no published Phase 1 or Phase 2 outcomes for this molecule, so the evidence level reflects what can actually be read rather than the stage reached.

Last documented development: 2026 — Phase 3 RENEW-ALC-1 and RENEW-ALC-2 recruiting

What it is

A biologic dual agonist of the glucose-dependent insulinotropic polypeptide (GIP) receptor and the glucagon-like peptide-1 (GLP-1) receptor, developed by Eli Lilly. Its registered late-stage programme targets psychiatric and addiction indications rather than weight management.

What people claim

  • Reduces alcohol craving and drinking
  • Treats alcohol use disorder
  • Improves depression
  • Incretin drugs 'cure' addiction

What the evidence actually says

What people claim: that incretin drugs including brenipatide reduce craving and treat addiction, often citing anecdotes and weight-loss experiences. What the evidence actually says: two large randomised, double-blind, placebo-controlled Phase 3 trials in alcohol use disorder (RENEW-ALC-1 and RENEW-ALC-2, about 1,100 participants each) are recruiting, with estimated primary completion in April 2028, and no efficacy results have been posted. Registered trials of this size mean the question is being taken seriously and tested properly; they are not an answer. Nothing here establishes that brenipatide reduces drinking, craving or depressive symptoms in people.

Related evidence

Useful next reads based on this compound — not recommendations.

Human evidence

  • NCT07219966 (RENEW-ALC-1): Phase 3, randomised, double-blind, placebo-controlled, estimated 1,100 adults with moderate-to-severe alcohol use disorder; recruiting, study start 15 October 2025, estimated primary completion April 2028.
  • NCT07219953 (RENEW-ALC-2): Phase 3, randomised, double-blind, placebo-controlled, estimated 1,100 adults with alcohol use disorder or hazardous alcohol use; recruiting, study start 16 October 2025, estimated primary completion April 2028. Registered outcomes include drinking patterns, alcohol consumption, craving, AUDIT score, body weight and safety.
  • Lilly's pipeline lists Phase 3 development in major depressive disorder; our curated record does not establish published results for that programme.
  • No Phase 3 efficacy results are posted for any indication.

Preclinical evidence

  • Dual GIP and GLP-1 receptor pharmacology is well characterised as a molecular class; the specific preclinical package for this molecule is not established in our curated record.

Animal and cell findings are Level 1–2 evidence.

Mechanism and pathways

  • GLP-1 receptor agonism acts on gut hormone signalling and on brain circuits involved in appetite and reward.
  • GIP receptor agonism adds a second incretin pathway alongside GLP-1 signalling.
  • Reward-pathway involvement is the stated rationale for testing incretin agonism in addiction; a plausible mechanism is a reason to run a trial, not a result.

Safety and unknowns

  • No safety dataset for this molecule is established in our curated record; safety is a registered outcome of the ongoing Phase 3 trials.
  • Class-level incretin effects such as gastrointestinal symptoms are expected considerations, but class expectations are not molecule-specific safety evidence.
  • Alcohol use disorder and major depressive disorder are serious conditions with established treatments; nothing on this profile is a reason to delay or replace clinical care.

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.

Monitored in trials; not demonstrated in humans

No demonstrated human cancer signal. Precautionary class-level considerations from incretin pharmacology apply and safety surveillance sits inside the ongoing trials.

Regulatory status

Not approved anywhere, for any indication. Brenipatide is not approved for alcohol use disorder, major depressive disorder, diabetes, obesity or any other use. Lilly's public pipeline lists it as a biologic entity in Phase 3 development for alcohol use disorder and major depressive disorder. Registered late-stage trials mean a sponsor is testing a hypothesis formally — they are not a regulatory decision and not evidence that the hypothesis is correct.

Evidence grade

L1Theory onlyVery low confidence in rating

Cell, receptor or computer work explaining how something could work in principle. No evidence yet that it does anything useful in people.

What would change our rating?

  • Posted or peer-reviewed Phase 3 results from RENEW-ALC-1 or RENEW-ALC-2.
  • Published Phase 1 or Phase 2 human data for this molecule.
  • Peer-reviewed publication of the major depressive disorder programme.
  • A regulatory submission or decision in any indication.

References and sources

Sources fully curated

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. 2026-09-11

    Added a new profile. Brenipatide (LY3537031) is a biologic dual agonist of the GIP and GLP-1 receptors listed on Eli Lilly's pipeline in Phase 3 development for alcohol use disorder and major depressive disorder. Two Phase 3 trials in alcohol use disorder are recruiting: RENEW-ALC-1 (NCT07219966, estimated N=1100, start 15 October 2025) and RENEW-ALC-2 (NCT07219953, estimated N=1100, start 16 October 2025), both randomised, double-blind and placebo-controlled with estimated primary completion in April 2028.

    L1Theory only
    Added because active Phase 3 development, plus growing online claims that incretin drugs reduce craving or treat addiction, make this a compound readers will encounter. No efficacy results have been posted for any indication, so under our rubric the evidence level reflects mechanism and registered trials rather than demonstrated human outcomes. Registered late-stage trials are a question being tested properly, not an answer: brenipatide is not approved for alcohol use disorder, depression or anything else, and it is not a weight-loss medicine. Reviewed 11 September 2026.