Brenipatide

DRUG17 trials

Sponsors

Eli Lilly & Co., Eli Lilly and Company

Conditions

Alcohol Use DisorderAsthmaBipolar DisorderChronic ObstructiveDepressive DisorderDepressive Disorder, MajorIrritable Bowel Syndrome DiarrheaIrritable Bowel Syndrome - Constipation

Phase 1

A Study of Brenipatide (LY3537031) in Healthy Participants With Overweight or Obesity

Active, not recruitingNCT07476118

Eli Lilly and CompanyObesity, Overweight

Start: 2026-03-18End: 2027-02-01Target: 150Updated: 2026-07-16

Phase 2

A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma

RecruitingNCT07219173

Eli Lilly and CompanyAsthma

Start: 2025-10-22End: 2028-06-01Target: 531Updated: 2026-08-21

A Study of Brenipatide in Adults Who Quit Smoking Cigarettes and Want to Avoid Relapse

RecruitingNCT07223840

Eli Lilly and CompanySmoking

Start: 2025-11-03End: 2027-02-01Target: 222Updated: 2026-08-21

A Study of Brenipatide in Adult Participants With Bipolar Disorder (RENEW-Bipolar-1)

RecruitingNCT07286175

Eli Lilly and CompanyBipolar Disorder

Start: 2025-11-24End: 2027-11-01Target: 400Updated: 2026-09-04

J2S-MC-GZMR: A Phase 2, Multicenter, Randomized, Double-blind, 52-week Study, to Investigate the Efficacy and Safety of Brenipatide Compared with Placebo for the Treatment of Adult Participants with Uncontrolled Moderate to Severe Asthma

Not yet recruitingCTIS2025-522640-41-00

Eli Lilly & Co.Asthma

Target: 73Updated: 2026-01-21

A Study of Brenipatide in Adult Participants With Schizophrenia

RecruitingNCT07410507

Eli Lilly and CompanySchizophrenia

Start: 2026-02-10End: 2027-11-01Target: 450Updated: 2026-09-04

A Study of Brenipatide in Participants With Opioid Use Disorder

RecruitingNCT07420283

Eli Lilly and CompanyOpioid Use Disorder

Start: 2026-02-13End: 2028-03-01Target: 465Updated: 2026-09-04

J2S-MC-GZMT: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Brenipatide in the Treatment of Adult Participants with IBS-C

Not yet recruitingCTIS2025-524974-41-00

Eli Lilly & Co.Irritable Bowel Syndrome - Constipation

Target: 70Updated: 2026-08-11

A Study of Brenipatide (LY3537031) in Adult Participants With Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD)

Not yet recruitingNCT07759245

Eli Lilly and CompanyPulmonary Disease, Chronic Obstructive

Start: 2026-08-01End: 2028-11-01Target: 606Updated: 2026-08-24

J2S-MC-GZMS: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Brenipatide in the Treatment of Adult Participants with IBS-D

Not yet recruitingCTIS2025-524973-17-00

Eli Lilly & Co.Irritable Bowel Syndrome Diarrhea

Target: 40Updated: 2026-08-20

J2S-MC-GZMV: A Phase 2, Multicenter, Randomized, Double-Blind, 52-week Study to Investigate the Efficacy and Safety of Brenipatide Compared With Placebo for the Treatment of Adult Participants With Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD)

Not yet recruitingCTIS2026-525480-41-00

Eli Lilly & Co.Chronic Obstructive, Pulmonary Disease

Target: 174Updated: 2026-09-16

Phase 3

J2S-MC-GZMP: A Phase 3, Multicenter, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Brenipatide Compared With Placebo for the Treatment of Adult Participants With Alcohol Use Disorder (RENEW-ALC-2)

Not yet recruitingCTIS2025-522312-16-00

Eli Lilly & Co.Alcohol Use Disorder

Target: 67Updated: 2026-01-29

J2S-MC-GZME: A Phase 3, Multicenter, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Brenipatide Compared with Placebo for the Treatment of Adult Participants with Moderate-to-Severe Alcohol Use Disorder (RENEW-ALC-1)

Not yet recruitingCTIS2025-522313-38-00

Eli Lilly & Co.Alcohol Use Disorder

Target: 47Updated: 2026-02-05

A Study of Brenipatide in Adult Participants With Major Depressive Disorder

RecruitingNCT07412756

Eli Lilly and CompanyDepressive Disorder, Major

Start: 2026-02-09End: 2028-02-01Target: 1000Updated: 2026-08-06

J2S-MC-GZMH: A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm Study to Investigate the Efficacy and Safety of Adjunctive Treatment With Brenipatide in Delaying Time to Relapse Compared With Placebo in Adult Participants With Major Depressive Disorder (RENEW-MDD 1)

Not yet recruitingCTIS2025-522308-25-00

Eli Lilly & Co.Major Depressive Disorder

Target: 98Updated: 2026-06-05

JS2-MC-GZMI: A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm Study to Investigate the Efficacy and Safety of Adjunctive Treatment with Brenipatide in Delaying Time to Relapse Compared with Placebo in Adult Participants with Major Depressive Disorder (RENEW-MDD- 2)

Not yet recruitingCTIS2025-522310-24-00

Eli Lilly & Co.Depressive Disorder, Major

Target: 46Updated: 2026-08-19

A Study of Brenipatide (LY3537031) in Adult Participants With Major Depressive Disorder

Not yet recruitingNCT07775300

Eli Lilly and CompanyDepressive Disorder, Major

Start: 2026-08-01End: 2029-02-01Target: 1000Updated: 2026-08-27