Brenipatide

What it is & what research shows

Reference overview

Brenipatide, also called LY3537031, is Lilly’s investigational peptide agonist of GIP and GLP-1 receptors. It shares these receptor targets with tirzepatide, but is a distinct molecule; retatrutide additionally activates the glucagon receptor. Receptor overlap does not establish interchangeable clinical effects, doses or safety. Its development is especially notable for studying conditions beyond weight management, including substance use and mood disorders. Two phase 3 alcohol use disorder trials, RENEW-ALC-1 and RENEW-ALC-2, are testing drinking outcomes. RENEW-MDD-1 tests whether adding brenipatide to standard depression care delays symptom recurrence; a separate bipolar trial addresses relapse alongside existing treatment. RENEW-Smk-1 studies people who have already quit cigarettes, while RENEW-Asthma studies uncontrolled moderate-to-severe asthma. These are investigational uses and trial questions, not established treatment benefits. [1.1][1.2][1.3][1.4][1.5][1.6][1.7][1.8]

Public trial registrations explain what researchers intend to measure, but enrollment targets and phase numbers are not efficacy results. Lilly’s September 2026 Psych Congress program lists early clinical data supporting dose selection and presentations describing the alcohol and depression programs. This profile does not infer numerical outcomes from those presentation titles. The reviewed RENEW-ALC-1 registry has no posted results. Trials of semaglutide provide a rationale for studying incretin drugs in addiction, but cannot establish that brenipatide works. Important unresolved questions include the size and durability of any benefit, discontinuations, adverse events, and whether effects remain after accounting for weight and metabolic changes. No dosing recommendation, definitive human half-life or claim of superior brain penetration is inferred here. A source-linked study result with a verified dose and schedule is not yet available in this overview. This is a gap in this page, not a claim that no research exists. [2.1][2.2][2.3]

Studied methods, not dosing advice. Selected evidence, not a complete literature review or formal quality appraisal.

Sources & reading scope

[1.1] Lilly clinical pipeline: brenipatide / LY3537031Sponsor or trial-registry description; investigational status and design
[1.2] Retatrutide: triple-receptor agonist obesity trialHuman trial of a different compound; contextual evidence only
[1.3] RENEW-ALC-1: phase 3 alcohol use disorder trialSponsor or trial-registry description; investigational status and design
[1.4] Lilly: RENEW-ALC-2 trial designSponsor or trial-registry description; investigational status and design
[1.5] Lilly: RENEW-MDD-1 adjunctive depression trialSponsor or trial-registry description; investigational status and design
[1.6] Lilly: RENEW-Bipolar-1 trial designSponsor or trial-registry description; investigational status and design
[1.7] Lilly: RENEW-Smk-1 smoking relapse prevention trialSponsor or trial-registry description; investigational status and design
[1.8] Lilly: RENEW-Asthma trial designSponsor or trial-registry description; investigational status and design
[2.1] RENEW-ALC-1: phase 3 alcohol use disorder trialSponsor or trial-registry description; investigational status and design
[2.2] Lilly Psych Congress 2026: brenipatide presentationsSponsor conference listing; not a full outcome report
[2.3] Hendershot et al.: randomized semaglutide trial in alcohol use disorderHuman trial of a different compound; contextual evidence only

Study-summary coverage

No completed study summaries are linked to this compound page yet. This is a coverage gap on PED Evidence, not evidence that human studies or other research do not exist.

Filter, save and compare Brenipatide studies →

Clinical trials & research materials

Direct access to brenipatide research, also listed under LY3537031. Trial records describe study plans and any posted results; a registration is not a published efficacy paper.

Trial records

Early clinical study of LY3537031 ↗
Research in overweight, obese and healthy participants. NCT06606106.
RENEW-ALC-1 · alcohol use disorder ↗
Phase 3 trial assessing drinking outcomes. NCT07219966.
RENEW-ALC-2 · alcohol use disorder ↗
Phase 3 trial studying hazardous drinking. NCT07219953.
RENEW-MDD-1 · major depressive disorder ↗
Adjunctive treatment trial studying return of depressive symptoms. NCT07412756.
RENEW-MDD-2 · major depressive disorder ↗
Phase 3 trial of brenipatide alongside current antidepressant treatment. NCT07775300.
RENEW-Bipolar-1 · bipolar disorder ↗
Trial studying relapse or worsening alongside standard care. NCT07286175.
RENEW-Smk-1 · smoking relapse prevention ↗
Trial in adults who have quit cigarettes and want to avoid returning to smoking.
RENEW-Asthma · uncontrolled asthma ↗
Trial in adults with uncontrolled moderate-to-severe asthma. NCT07219173.

Conference posters · Psych Congress 2026

Materials provided by Lilly. Conference posters are distinct from peer-reviewed journal papers.

Clinical data supporting dose selection · open poster ↗
Brenipatide development across substance use, psychiatric and immunologic disorders.
Major depressive disorder trial program · open poster ↗
Presentation describing the brenipatide depression trial.
Alcohol use disorder trial program · open poster ↗
Presentation describing the brenipatide alcohol use disorder trials.

Sources checked September 24, 2026. View Lilly’s conference program.

More about Brenipatide: identity, safety & reference details

PeptideMetabolism

Primary research area: Emerging research
Regulatory status: Research status varies
Evidence level: Evidence level not yet characterized
Primary mechanism: Mechanism not yet characterized

Reference profile available · Coverage varies by section

Also known as LY3537031 · LY-3537031

Start with the research

An outcome-specific synthesis has not been prepared for this compound. This is a coverage gap, not evidence that it has no effect.

Open studies and trial records

Uses & research: Two phase 3 alcohol use disorder trials, RENEW-ALC-1 and RENEW-ALC-2, are testing drinking outcomes. RENEW-MDD-1 tests whether adding brenipatide to standard depression care delays symptom recurrence; a separate bipolar trial addresses relapse alongside existing treatment. RENEW-Smk-1 studies people who have already quit cigarettes, while RENEW-Asthma studies uncontrolled moderate-to-severe asthma. These are investigational uses and trial questions, not established treatment benefits. [3][4][5][6][7][8]
Known half-life: No source-verified value in this profile yet. A treatment schedule or duration of an effect is not a drug half-life.
Half-life describes how quickly the measured drug concentration falls by half. It does not set a dosing interval.
Evidence & important limits: Public trial registrations explain what researchers intend to measure, but enrollment targets and phase numbers are not efficacy results. Lilly’s September 2026 Psych Congress program lists early clinical data supporting dose selection and presentations describing the alcohol and depression programs. This profile does not infer numerical outcomes from those presentation titles. The reviewed RENEW-ALC-1 registry has no posted results. Trials of semaglutide provide a rationale for studying incretin drugs in addiction, but cannot establish that brenipatide works. Important unresolved questions include the size and durability of any benefit, discontinuations, adverse events, and whether effects remain after accounting for weight and metabolic changes. No dosing recommendation, definitive human half-life or claim of superior brain penetration is inferred here. [3][9][10]

Safety & evidence boundaries

Source-specific information, not a personal safety clearance or monitoring plan.

RENEW-ALC-1: phase 3 alcohol use disorder trial Lilly Psych Congress 2026: brenipatide presentations Hendershot et al.: randomized semaglutide trial in alcohol use disorder

Explore safety questions by system

These are literature filters, not claims that this compound causes each effect. A keyword match is not a confirmed adverse reaction.

Heart, blood pressure & lipids Liver injury Kidney function Glucose effects Reproductive & endocrine effects Mood & sleep Adverse effects & interactions

Interactions, rare harms, long-term effects and reversibility require separate evidence. Do not infer they are absent when the sources here do not address them.

Identity, names & formulations

Canonical compound: Brenipatide · brenipatide

Searchable names: LY3537031, LY-3537031

Names share a parent research page. Different esters, salts, routes and brands are not assumed to have the same half-life, indication or exposure.

Investigational GIP/GLP-1 receptor agonist; addiction and mood trial programs do not establish clinical benefit.

Combination evidence stays attached to the studied combination. It is not automatically assigned to each ingredient.

Understand the evidence types

Read the model and design first, then the population, outcome and limitations. These categories describe evidence, not a best-compound ranking.

Randomized human trials: Compare assigned interventions. Randomization does not by itself establish low bias or relevance to every population.
Controlled human studies: Use a comparison group; allocation and confounding still matter.
Prospective human research: Follows participants forward. It may be observational or interventional, so this is not a separate quality grade.
Observational human research: Describes associations. Confounding can explain differences.
Case reports and series: Useful for unusual events and safety signals, not reliable rates or effect sizes.
Animal research: Can test biology and function in a living model. Human exposure, benefit and safety remain separate questions.
Cell and tissue research: Tests responses in a preparation, including human-derived cells. It is not a human participant trial.
Mechanistic and computational evidence: Helps explain or predict a pathway; predictions need experimental and clinical testing.
Anecdotal reports: Self-reported experiences can generate questions. Product identity, selection bias and other interventions may be uncontrolled.

Systematic reviews synthesize studies and depend on their quality. Preprint status and abstract versus full-paper reading are separate labels. Citation popularity measures attention, not reliability. A study summary is not a formal quality appraisal.

Sources for this profile

1. Lilly clinical pipeline: brenipatide / LY3537031 Sponsor or trial-registry description; investigational status and design
2. Retatrutide: triple-receptor agonist obesity trial Human trial of a different compound; contextual evidence only
3. RENEW-ALC-1: phase 3 alcohol use disorder trial Sponsor or trial-registry description; investigational status and design
4. Lilly: RENEW-ALC-2 trial design Sponsor or trial-registry description; investigational status and design
5. Lilly: RENEW-MDD-1 adjunctive depression trial Sponsor or trial-registry description; investigational status and design
6. Lilly: RENEW-Bipolar-1 trial design Sponsor or trial-registry description; investigational status and design
7. Lilly: RENEW-Smk-1 smoking relapse prevention trial Sponsor or trial-registry description; investigational status and design
8. Lilly: RENEW-Asthma trial design Sponsor or trial-registry description; investigational status and design
9. Lilly Psych Congress 2026: brenipatide presentations Sponsor conference listing; not a full outcome report
10. Hendershot et al.: randomized semaglutide trial in alcohol use disorder Human trial of a different compound; contextual evidence only

Reference facts checked 2026-09-24. Source scope is listed above; this is not a formal quality appraisal. See each label for full prescribing information.

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Research outcomeResearch model

Study model describes the source. Confidence depends on methods, replication, population and outcome.

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