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

RENEW-MDD- 2: A Study of Brenipatide (LY3537031) 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-COPD: A Study of Brenipatide (LY3537031) in Adult Participants With Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD) (clinicaltrials.gov) - P2 | N=606 | Not yet recruiting | Sponsor: Eli Lilly and Company

New P2 trial • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

A Study of How the Body Absorbs LY3537031 (clinicaltrials.gov) - P1 | N=47 | Completed | Sponsor: Eli Lilly and Company | Active, not recruiting ➔ Completed

Trial completion

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

Enrollment closed • Genetic Disorders • Obesity

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-IBS-D: A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D) (clinicaltrials.gov) - P2 | N=531 | Not yet recruiting | Sponsor: Eli Lilly and Company

New P2 trial • Gastrointestinal Disorder

RENEW-IBS-C: A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C) (clinicaltrials.gov) - P2 | N=342 | Recruiting | Sponsor: Eli Lilly and Company | Not yet recruiting ➔ Recruiting

Enrollment open • Constipation • Gastroenterology • Gastrointestinal Disorder

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

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-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-IBS-C: A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C) (clinicaltrials.gov) - P2 | N=342 | Not yet recruiting | Sponsor: Eli Lilly and Company

New P2 trial • Constipation • Gastroenterology • Gastrointestinal Disorder

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-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

RENEW-IBS-D: A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D) (clinicaltrials.gov) - P2 | N=531 | Recruiting | Sponsor: Eli Lilly and Company | Not yet recruiting ➔ Recruiting

Enrollment open • Gastrointestinal Disorder

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 | Recruiting | Sponsor: Eli Lilly and Company

Trial initiation date • Addiction (Opioid and Alcohol)

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)

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

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)

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

Trial initiation date

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

Trial initiation date • Bipolar Disorder • CNS Disorders • 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=31 | Completed | Sponsor: Eli Lilly and Company | Active, not recruiting ➔ Completed

Trial completion • Chronic Kidney Disease • Nephrology • Renal Disease

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

Enrollment open • 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 | Trial primary completion date: Aug 2027 ➔ Mar 2028

Trial primary completion date • Substance Abuse