brenipatide (LY-3537031) / Eli Lilly - LARVOL DELTA

RENEW-Scz-1: A Study of Brenipatide in Adult Participants With Schizophrenia (clinicaltrials.gov) - P2 | N=450 | Recruiting | Sponsor: Eli Lilly and Company | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Psychiatry • Schizophrenia

RENEW-MDD-1: A Study of Brenipatide in Adult Participants With Major Depressive Disorder (clinicaltrials.gov) - P3 | N=1000 | Recruiting | Sponsor: Eli Lilly and Company | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

A Study of Pharmacokinetics and Safety of LY3537031 in Participants With Normal Renal Function and Participants With Renal Impairment (clinicaltrials.gov) - P1 | N=32 | Active, not recruiting | Sponsor: Eli Lilly and Company | Recruiting ➔ Active, not recruiting

Enrollment closed • Chronic Kidney Disease • Nephrology • Renal Disease

RENEW-ALC-1: A Study of Brenipatide in Participants With Moderate-to-Severe Alcohol Use Disorder (clinicaltrials.gov) - P3 | N=1100 | Recruiting | Sponsor: Eli Lilly and Company

Trial initiation date • Addiction (Opioid and Alcohol)

A Study of Brenipatide (LY3537031) in Healthy Participants With Overweight or Obesity (clinicaltrials.gov) - P1 | N=150 | Not yet recruiting | Sponsor: Eli Lilly and Company

New P1 trial • Genetic Disorders • Obesity

RENEW-Op-1: A Study of Brenipatide in Participants With Opioid Use Disorder (clinicaltrials.gov) - P2 | N=465 | Recruiting | Sponsor: Eli Lilly and Company | Not yet recruiting ➔ Recruiting

Enrollment open • Substance Abuse

RENEW-ALC-2: A Study of Brenipatide in Participants With Alcohol Use Disorder (clinicaltrials.gov) - P3 | N=1100 | Recruiting | Sponsor: Eli Lilly and Company

Trial initiation date • Addiction (Opioid and Alcohol)

J2S-MC-GZML: A Study of LY3537031 in Participants With Normal Liver Function and With Mild, Moderate, or Severe Liver Impairment (clinicaltrialsregister.eu) - P1 | N=26 | Recruiting | Sponsor: Eli Lilly & Co.

New P1 trial • Hepatitis C • Liver Failure

RENEW-Op-1: A Study of Brenipatide in Participants With Opioid Use Disorder (clinicaltrials.gov) - P2 | N=465 | Not yet recruiting | Sponsor: Eli Lilly and Company

New P2 trial • Substance Abuse

RENEW-MDD-1: A Study of Brenipatide in Adult Participants With Major Depressive Disorder (clinicaltrials.gov) - P3 | N=1000 | Not yet recruiting | Sponsor: Eli Lilly and Company

New P3 trial • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

RENEW-Scz-1: A Study of Brenipatide in Adult Participants With Schizophrenia (clinicaltrials.gov) - P2 | N=450 | Not yet recruiting | Sponsor: Eli Lilly and Company

New P2 trial • CNS Disorders • Psychiatry • Schizophrenia

A Study of How the Body Absorbs LY3537031 (clinicaltrials.gov) - P1 | N=46 | Active, not recruiting | Sponsor: Eli Lilly and Company | Recruiting ➔ Active, not recruiting

Enrollment closed

A Study of Brenipatide in Adult Participants With Bipolar Disorder (RENEW-Bipolar-1) (clinicaltrials.gov) - P2 | N=400 | Recruiting | Sponsor: Eli Lilly and Company

New P2 trial • Bipolar Disorder • CNS Disorders • Mood Disorders • Psychiatry

RENEW-ALC-1: A Study of Brenipatide in Participants With Moderate-to-Severe Alcohol Use Disorder (clinicaltrials.gov) - P3 | N=1100 | Recruiting | Sponsor: Eli Lilly and Company | Not yet recruiting ➔ Recruiting

Enrollment open • Addiction (Opioid and Alcohol)

RENEW-Smk-1: A Study of Brenipatide in Adults Who Quit Smoking Cigarettes and Want to Avoid Relapse (clinicaltrials.gov) - P2 | N=222 | Recruiting | Sponsor: Eli Lilly and Company | Not yet recruiting ➔ Recruiting

Enrollment open

RENEW-ALC-2: A Study of Brenipatide in Participants With Alcohol Use Disorder (clinicaltrials.gov) - P3 | N=1100 | Recruiting | Sponsor: Eli Lilly and Company | Not yet recruiting ➔ Recruiting

Enrollment open • Addiction (Opioid and Alcohol)

A Study of How the Body Absorbs LY3537031 (clinicaltrials.gov) - P1 | N=46 | Recruiting | Sponsor: Eli Lilly and Company | Not yet recruiting ➔ Recruiting | Trial primary completion date: Jan 2026 ➔ Sep 2026

Enrollment open • Trial primary completion date

A Study of the Pharmacokinetics and Safety of LY3537031 in Participants With Normal Liver Function and With Mild, Moderate, or Severe Liver Impairment (clinicaltrials.gov) - P1 | N=32 | Recruiting | Sponsor: Eli Lilly and Company | Not yet recruiting ➔ Recruiting

Enrollment open • Hepatitis C • Hepatology • Liver Failure

RENEW-Smk-1: A Study of Brenipatide in Adults Who Quit Smoking Cigarettes and Want to Avoid Relapse (clinicaltrials.gov) - P2 | N=222 | Not yet recruiting | Sponsor: Eli Lilly and Company

New P2 trial

A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma (clinicaltrials.gov) - P2 | N=531 | Not yet recruiting | Sponsor: Eli Lilly and Company

New P2 trial • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma (clinicaltrials.gov) - P2 | N=531 | Recruiting | Sponsor: Eli Lilly and Company | Not yet recruiting ➔ Recruiting

Enrollment open • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

RENEW-ALC-2: A Study of Brenipatide in Participants With Alcohol Use Disorder (clinicaltrials.gov) - P3 | N=1100 | Not yet recruiting | Sponsor: Eli Lilly and Company

New P3 trial • Addiction (Opioid and Alcohol)

RENEW-ALC-1: A Study of Brenipatide in Participants With Moderate-to-Severe Alcohol Use Disorder (clinicaltrials.gov) - P3 | N=1100 | Not yet recruiting | Sponsor: Eli Lilly and Company

New P3 trial • Addiction (Opioid and Alcohol)

A Study of Pharmacokinetics and Safety of LY3537031 in Participants With Normal Renal Function and Participants With Renal Impairment (clinicaltrials.gov) - P1 | N=32 | Recruiting | Sponsor: Eli Lilly and Company | Not yet recruiting ➔ Recruiting

Enrollment open • Chronic Kidney Disease • Nephrology • Renal Disease

A Study of LY3537031 in Overweight, Obese, and Healthy Participants (clinicaltrials.gov) - P1 | N=302 | Active, not recruiting | Sponsor: Eli Lilly and Company | Recruiting ➔ Active, not recruiting

Enrollment closed • Genetic Disorders • Obesity