Brenipatide (development code LY3537031) is an investigational peptide that activates the GIP and GLP-1 receptors, the same pair as tirzepatide. What sets it apart is where it is being tested. Of the nine studies listed on ClinicalTrials.gov as of 30 October 2026, seven sit under the name RENEW, and none of those seven is an obesity or diabetes trial. This post goes through what each study measures and when the registry expects results. For the pharmacology and the background evidence, see our brenipatide research overview.
The nine studies at a glance
| Study | Condition | Phase | Primary completion (registry estimate) |
|---|---|---|---|
| RENEW-Smk-1 | Relapse to smoking | 2 | February 2027 |
| Phase 1b | Overweight or obesity | 1b | February 2027 |
| RENEW-Bipolar-1 | Bipolar disorder | 2 | November 2027 |
| RENEW-Scz-1 | Schizophrenia | 2 | November 2027 |
| RENEW-MDD-1 | Major depressive disorder | 3 | February 2028 |
| RENEW-Op-1 | Opioid use disorder | 2 | March 2028 |
| RENEW-ALC-1 | Alcohol use disorder | 3 | April 2028 |
| RENEW-Asthma | Uncontrolled asthma | 2 | April 2028 |
| First-in-human | Healthy participants | 1 | Completed June 2021 |
Registry completion dates are the sponsor's estimates and often move.
Addiction: alcohol, opioids and smoking
RENEW-ALC-1 (NCT07219966) is the largest study in the programme: about 1,100 adults with moderate to severe alcohol use disorder, randomised to brenipatide or placebo. Its primary outcome is change in drinking patterns measured with the Timeline Followback method, a structured day-by-day recall of drinking, over up to 56 weeks.
RENEW-Op-1 (NCT07420283) enrols about 465 people with opioid use disorder in early recovery, all taking buprenorphine. It asks whether adding brenipatide increases the share of weeks without opioid use, confirmed by both urine tests and self-report, between weeks 13 and 24.
RENEW-Smk-1 (NCT07223840) enrols about 222 adults who have recently stopped smoking and measures continuous abstinence, confirmed by exhaled carbon monoxide, over 24 weeks. It is the smallest RENEW trial and is expected to report first.
The rationale for all three comes from GLP-1 receptors in brain reward areas. Earlier human trials of GLP-1 drugs alone were small and gave mixed results: exenatide did not reduce heavy drinking days overall in 127 people, while semaglutide reduced some drinking measures and craving in 48 adults, but not the number of drinking days.
Mood disorders and schizophrenia
RENEW-MDD-1 (NCT07412756, phase 3, about 1,000 participants) and RENEW-Bipolar-1 (NCT07286175, phase 2, about 400) share a design: brenipatide or placebo added to standard care, with the primary outcome the time until a participant meets the criteria for relapse. These are relapse-prevention trials, not trials of treating an active episode.
RENEW-Scz-1 (NCT07410507, phase 2, about 450 participants) also adds brenipatide to standard care, but its primary outcome is percentage change in body weight at 52 weeks in participants with a BMI of 25 or more. That points to weight gain on antipsychotic medicines as the target, rather than the symptoms of schizophrenia themselves.
Asthma
RENEW-Asthma (NCT07219173, phase 2, about 531 participants) is the outlier. It tests brenipatide against placebo in adults with uncontrolled moderate to severe asthma and measures the yearly rate of asthma attacks over 52 weeks. The registry tags the study with the keyword "Incretin" but the record gives no rationale. Secondary outcomes include lung function (FEV1), time to first attack and use of rescue medication.
Metabolism: two phase 1 studies
A first-in-human study (NCT04648865) gave single doses or placebo to 40 healthy participants in Japan between December 2020 and June 2021. A phase 1b study (NCT07476118) in about 150 people with overweight or obesity measures percentage change in body weight at 29 weeks. It will be the first source of brenipatide weight data.
What has been reported
Only phase 1 findings so far. A poster at Psych Congress 2026 in September, reported by Psychiatric Times, gave a half-life of 9 to 12 days, longer than tirzepatide's, and said gastrointestinal effects were the most common adverse events, at comparable rates on brenipatide and placebo. No efficacy result from any RENEW trial has been published.
What to watch
- 2027: the smoking relapse trial and the phase 1b obesity study are due to complete first, followed by the bipolar disorder and schizophrenia trials.
- 2028: the two phase 3 trials (alcohol use disorder and major depressive disorder), the opioid trial and the asthma trial.
Brenipatide is not approved anywhere. See the brenipatide profile for the full trial register, or compare it with tirzepatide, retatrutide and semaglutide. Brenipatide is not yet stocked by Peptx; the profile page has a sign-up for availability notices.
References
- ClinicalTrials.gov. Studies of brenipatide (LY3537031): NCT07219966, NCT07412756, NCT07223840, NCT07420283, NCT07286175, NCT07410507, NCT07219173, NCT07476118, NCT04648865. Records read 30 October 2026. ClinicalTrials.gov
- Goldsmith P, Garhyan P, Yan S, et al. Brenipatide, a GIP/GLP-1 receptor agonist: clinical data supporting dose selection for substance use, psychiatric, and immunologic disorders. Poster, Psych Congress 2026, New Orleans, 15 to 19 September 2026. Reported in Psychiatric Times, 18 September 2026.
- Klausen MK, et al. "Exenatide once weekly for alcohol use disorder investigated in a randomized, placebo-controlled clinical trial." JCI Insight. 2022. PubMed 36066977
- Hendershot CS, et al. "Once-Weekly Semaglutide in Adults With Alcohol Use Disorder: A Randomized Clinical Trial." JAMA Psychiatry. 2025. PubMed 39937469