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Brenipatide Phase 3: GLP-1 and Addiction

Brenipatide's Phase 1 data is early, conference-grade. Phase 3 alcohol and depression trials are running but not read out; no addiction use is approved.

By PeptidesBeat Staff

Last reviewed

Quick answer: No GLP-1 medicine is approved to treat any addiction. Eli Lilly presented early, conference-grade Phase 1 data for its investigational GIP/GLP-1 candidate brenipatide at Psych Congress 2026 (New Orleans, September 15–19) and detailed the design of Phase 3 trials in alcohol use disorder and major depressive disorder — but those trials have not read out, results are expected around mid-2028, and the drug is not approved for any use. The picture is genuinely split: observational studies and target-trial emulations consistently point to lower alcohol use, while the small randomised trials of other GLP-1s have hit some endpoints and missed others, and their authors call for larger trials. This is a research story about a drug still being tested, not a treatment story.

Eli Lilly presented early clinical data supporting dose selection for brenipatide (LY3537031), a long-acting dual GIP/GLP-1 receptor agonist in development for substance use, psychiatric and immunologic disorders, at Psych Congress 2026 in New Orleans (September 15–19), and set out the design of two Phase 3 programs, in major depressive disorder and alcohol use disorder (GEN, September 19, 2026). Psychiatric Times, covering the same conference poster, describes the drug as dosed weekly by subcutaneous injection, on a half-life of roughly nine to twelve days.

The consumer version of the question is circulating at the same time: a September 19 headline in the Google News index — “Could Ozempic be used to treat addiction? Why the question has split researchers”, published by the Sydney Morning Herald — asks it directly. That article was not fetched for this post, and nothing below depends on it.

What Lilly Presented at Psych Congress 2026

The poster — “Brenipatide, a GIP/GLP-1 receptor agonist: clinical data supporting dose selection for substance use, psychiatric, and immunologic disorders” — was presented on Friday, September 18 (Psychiatric Times). Its reported conclusion is that the data “support the selection of weekly maintenance doses across a broad range of BMIs, including normal body weight, that optimize safety, tolerability, and incretin pharmacology” (GEN).

The Phase 1 Study Behind the Data

The underlying study is Phase 1 NCT06606106, a multiple-ascending-dose trial in healthy, overweight and obese volunteers with an eight-week follow-up. Doses ran from 0.3 mg to 4.5 mg, with a mean half-life of 9.08 to 12.5 days, longest at the top dose (GEN). GEN reports more than 200 participants across three study parts; the registry describes four parts and 302 planned participants.

What the Data Does and Does Not Show

The study met its primary outcome — and that outcome was safety, not efficacy. Lilly reported no deaths and no serious adverse events, with four participants (2.2%) discontinuing for a treatment-emergent adverse event; gastrointestinal events occurred in 25% of both the brenipatide and the placebo arms, and dysesthesia-related events in 15.2% of brenipatide-treated participants and none on placebo (GEN). What the data do not show is whether brenipatide works: there is no human efficacy result for it in AUD or MDD, and the participants were healthy, overweight and obese volunteers rather than patients with either condition. The class-wide tolerability picture is the subject of our underreported GLP-1 side effects analysis.

The Phase 3 Trials: Designed, Not Read Out

Two Phase 3 AUD trials are recruiting — NCT07219966 and NCT07219953 — each planning about 1,100 participants, with primary completion estimated for April 2028 and a primary endpoint of change in drinking patterns measured with the Timeline Followback method: deliberately not abstinence. Lilly advanced brenipatide straight to Phase 3 in these populations rather than running Phase 2 first (GEN). In MDD, NCT07412756 is recruiting about 1,000 participants across 14 countries with time to relapse as its endpoint, and NCT07775300 was first posted on August 20, 2026 and is not yet recruiting. AUD results are expected by mid-2028 (Psychiatric Times). Brenipatide is subcutaneous, while part of the field moves toward oral delivery — Novo’s $1.4B oral macrocycle peptide deal with Orbis is the clearest recent example.

Why Researchers Are Split on GLP-1s for Addiction

Where the evidence agrees, it is mostly observational: a target-trial emulation across more than 120 million US health records found tirzepatide and semaglutide associated with a lower incidence of alcohol use disorder than DPP-4 inhibitors (hazard ratios 0.47, 95% CI 0.29–0.75, and 0.68, 0.52–0.89) (Diabetes Obes Metab 2026), and a meta-analysis found a 0.64 hazard ratio for alcohol-related events while noting that randomised effects on consumption and craving remained non-significant (Addict Sci Clin Pract 2025).

Where it breaks down is the randomised trials, which are small and endpoint-dependent. A nine-week trial in 48 non-treatment-seeking adults hit its primary laboratory-drinking endpoint but not drinks per calendar day or number of drinking days (JAMA Psychiatry 2025); a 50-person trial of oral semaglutide missed its primary craving endpoint even as heavy drinking days fell (Am J Psychiatry 2026); the largest randomised result — 26 weeks in 108 patients with AUD and comorbid obesity — found a treatment difference of -13.7 heavy drinking days (95% CI -22.0 to -5.4, p=0.0015) (The Lancet 2026). Those trials tested semaglutide, not brenipatide, which has no efficacy readout at all. PeptidesBeat has covered one adjacent signal — the semaglutide bipolar hospitalization signal, an observational association, not a treatment effect — and the same push into non-metabolic indications appears in the Elvinix–Zealand GLP-1/gastrin dual-agonist license.

What This Does NOT Prove

  • Brenipatide is not approved for any use. As of September 19, 2026, the FDA’s public drug-label and Drugs@FDA records return nothing for it (openFDA, Drugs@FDA); there is no approved psychiatric or addiction indication and no prescription product.
  • No human efficacy data exists in AUD or MDD. The Phase 1 primary endpoint was safety, and the trials that could answer the efficacy question are still enrolling.
  • Lilly’s stated rationale is mechanistic plus anecdotal: GLP-1 receptors in reward-linked brain regions, and patient reports of reduced craving on approved incretins (Psychiatric Times).
  • Most of the class signal is observational, and the randomised evidence is small and endpoint-dependent — its own authors say so.
  • The tolerability figures are Phase 1 class effects in a healthy and overweight population, not a safety profile for patients with AUD or MDD.
  • What is real about the class is metabolic: Sandoz’s authorized generic semaglutide in Canada is on the market for diabetes, while no GLP-1 has an addiction indication anywhere. Alcohol use disorder has three FDA-approved medications — naltrexone, acamprosate and disulfiram (NIAAA) — and anyone weighing a GLP-1 for drinking should raise it with a clinician rather than self-treat.

Frequently Asked Questions

Can GLP-1 drugs treat addiction?

Not yet. No GLP-1 medicine is approved to treat any addiction, and the evidence is early and mixed. The strongest signals are observational: a 2026 target-trial emulation across more than 120 million US health records found lower rates of newly diagnosed alcohol use disorder with tirzepatide and semaglutide (hazard ratios 0.47 and 0.68 versus DPP-4 inhibitors). The randomised trials are smaller and split — one hit its primary laboratory-drinking endpoint but not drinks per calendar day, and an oral semaglutide trial missed its primary craving endpoint. The reviewers’ own conclusion is that larger randomised trials are needed, which is what brenipatide’s Phase 3 program is testing. This article is not medical advice.

Can Ozempic treat alcoholism?

No. Ozempic (semaglutide) is not approved for alcohol use disorder anywhere, and what exists is a research signal rather than a treatment claim. The largest randomised result to date — 26 weeks in 108 patients with alcohol use disorder and comorbid obesity — reported a reduction in heavy drinking days (treatment difference -13.7 points, 95% CI -22.0 to -5.4, p=0.0015), while a separate 50-person trial of oral semaglutide missed its primary craving endpoint. Alcohol use disorder has three FDA-approved medications — naltrexone, acamprosate and disulfiram — and anyone considering a GLP-1 for drinking should raise it with a clinician rather than self-treat. This is not medical advice.

Is brenipatide a once-monthly GLP-1?

The current record points to weekly, not once-monthly. Both September 2026 conference reports describe brenipatide as dosed weekly by subcutaneous injection, and the Phase 1 data Lilly presented supported once-weekly maintenance dosing on a reported half-life of 9 to 12 days. The once-monthly description traces to an encyclopedia entry and to vendor pages citing a December 2025 review whose full text is not public. Treat the interval as provisional: this data is early and conference-grade, the Phase 1 primary endpoint was safety rather than efficacy, and no regulator has approved the drug for anything.

Is brenipatide approved for alcohol use disorder or depression?

No. Brenipatide is an investigational drug with no approved indication anywhere; as of September 19, 2026, the FDA’s public label, NDC and Drugs@FDA records return nothing for it. It is a Phase 3 candidate for moderate-to-severe alcohol use disorder, and Phase 3 trials in alcohol use disorder and major depressive disorder are running but not read out, with results expected around mid-2028. Phase 3 means the trials are designed and enrolling, not that they succeeded.

The Bottom Line

Brenipatide is the test, not the answer: a Phase 3 candidate for moderate-to-severe alcohol use disorder whose program is designed to read out around mid-2028, in a field where the observational signal is consistent and the randomised evidence is not yet. No GLP-1 is approved for addiction or for depression, and nothing here is a treatment recommendation.

Disclaimer: This article is for educational purposes only and is not medical advice. GLP-1 receptor agonists and peptide-based treatments are prescription therapies that should only be prescribed and monitored by qualified, licensed healthcare providers. Brenipatide is an investigational drug and is not approved for any indication. Always discuss your individual health situation with a clinician.

PeptidesBeat is an independent editorial publication covering peptide policy, research, and industry developments. We do not sell peptides, recommend dosing, or provide medical advice. All content is informational. Peptides referenced may be subject to FDA restrictions; consult a licensed healthcare provider for any therapeutic question.

Sources

The Sydney Morning Herald item “Could Ozempic be used to treat addiction? Why the question has split researchers” (September 19, 2026) appears in this article only as an indexed headline. It was not fetched, and no claim above is drawn from its content.

Educational content, not medical advice. © 2026 PeptidesBeat.