naperiglipron (LY3549492) / Eli Lilly - LARVOL DELTA

Lilly ends 2 of 3 midstage trials for oral GLP-1 contender naperiglipron (FierceBiotech) - "One of these trials was enrolling patients who are overweight or with obesity with Type 2 diabetes, while the other was aimed at adults with a 'healthy body mass index'."

Trial termination • Obesity • Type 2 Diabetes Mellitus

A Study of LY3549492 in Adults With Obesity or Overweight With Type 2 Diabetes (clinicaltrials.gov) - P2 | N=1 | Terminated | Sponsor: Eli Lilly and Company | N=150 ➔ 1 | Trial completion date: Nov 2026 ➔ Jul 2025 | Not yet recruiting ➔ Terminated | Trial primary completion date: Sep 2026 ➔ Jul 2025; Study terminated for strategic business reasons

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

A Study of LY3549492 in Healthy Weight Adult Participants (clinicaltrials.gov) - P2 | N=1 | Terminated | Sponsor: Eli Lilly and Company | N=220 ➔ 1 | Trial completion date: Feb 2027 ➔ Aug 2025 | Not yet recruiting ➔ Terminated | Trial primary completion date: Jan 2027 ➔ Aug 2025; Study terminated for strategic business reasons

Enrollment change • Trial completion date • Trial primary completion date • Trial termination

A Study of LY3549492 in Healthy Weight Adult Participants (clinicaltrials.gov) - P2 | N=220 | Not yet recruiting | Sponsor: Eli Lilly and Company

New P2 trial

A Master Protocol Study (LY900038) of Multiple Intervention-Specific-Appendices (ISAs) in Adult Participants With Obesity or Overweight (clinicaltrials.gov) - P2 | N=1217 | Recruiting | Sponsor: Eli Lilly and Company | Trial primary completion date: Jun 2026 ➔ Sep 2026

Trial primary completion date • Genetic Disorders • Obesity

A Study of LY3549492 in Chinese Participants With Type 2 Diabetes Mellitus (clinicaltrials.gov) - P1 | N=36 | Not yet recruiting | Sponsor: Eli Lilly and Company

New P1 trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

A Study of LY3549492 in Adults With Obesity or Overweight With Type 2 Diabetes (clinicaltrials.gov) - P2 | N=150 | Not yet recruiting | Sponsor: Eli Lilly and Company

New P2 trial • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

A Study of LY3549492 in Japanese Participants With Type 2 Diabetes Mellitus (T2D) and Healthy Japanese Participants (clinicaltrials.gov) - P1 | N=90 | Recruiting | Sponsor: Eli Lilly and Company | Not yet recruiting ➔ Recruiting

Enrollment open • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

A Study to Investigate Weight Management With LY3549492 Compared With Placebo in Adult Participants With Obesity or Overweight (clinicaltrials.gov) - P2 | N=275 | Active, not recruiting | Sponsor: Eli Lilly and Company | Recruiting ➔ Active, not recruiting

Enrollment closed • Genetic Disorders • Obesity

A Study of LY3549492 in Japanese Participants with Type 2 Diabetes Mellitus (T2D) and Healthy Japanese Participants (clinicaltrials.gov) - P1 | N=90 | Not yet recruiting | Sponsor: Eli Lilly and Company

New P1 trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

A Study to Investigate Weight Management With LY3549492 Compared With Placebo in Adult Participants With Obesity or Overweight (clinicaltrials.gov) - P2 | N=275 | Recruiting | Sponsor: Eli Lilly and Company | Not yet recruiting ➔ Recruiting

Enrollment open • Genetic Disorders • Obesity

A Master Protocol Study (LY900038) of Multiple Intervention-Specific-Appendices (ISAs) in Adult Participants With Obesity or Overweight (clinicaltrials.gov) - P2 | N=1040 | Recruiting | Sponsor: Eli Lilly and Company | N=765 ➔ 1040

Enrollment change • Genetic Disorders • Obesity

A Study to Investigate Weight Management With LY3549492 Compared With Placebo in Adult Participants With Obesity or Overweight (clinicaltrials.gov) - P2 | N=275 | Not yet recruiting | Sponsor: Eli Lilly and Company

New P2 trial • Genetic Disorders • Obesity

A Study of LY3549492 in Participants With Type 2 Diabetes Mellitus (T2DM) (clinicaltrials.gov) - P1 | N=80 | Completed | Sponsor: Eli Lilly and Company | Active, not recruiting ➔ Completed

Trial completion • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

A Study of Carbon-14-Labeled [14C]-LY3549492 in Healthy Participants (clinicaltrials.gov) - P1 | N=18 | Completed | Sponsor: Eli Lilly and Company | Recruiting ➔ Completed

Trial completion

A Study of LY3549492 in Participants With Type 2 Diabetes Mellitus (T2DM) (clinicaltrials.gov) - P1 | N=96 | Active, not recruiting | Sponsor: Eli Lilly and Company | Recruiting ➔ Active, not recruiting

Enrollment closed • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

A Study of Carbon-14-Labeled [14C]-LY3549492 in Healthy Participants (clinicaltrials.gov) - P1 | N=16 | Recruiting | Sponsor: Eli Lilly and Company

New P1 trial

A Study of LY3549492 in Participants With Type 2 Diabetes Mellitus (T2DM) (clinicaltrials.gov) - P1 | N=96 | Recruiting | Sponsor: Eli Lilly and Company | Trial completion date: Mar 2023 ➔ Mar 2024 | Trial primary completion date: Mar 2023 ➔ Mar 2024

Trial completion date • Trial primary completion date • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

A Study of LY3549492 in Participants With Type 2 Diabetes Mellitus (T2DM) (clinicaltrials.gov) - P1 | N=96 | Recruiting | Sponsor: Eli Lilly and Company | Not yet recruiting ➔ Recruiting

Enrollment open • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

A Study of LY3549492 in Participants With Type 2 Diabetes Mellitus (T2DM) (clinicaltrials.gov) - P1 | N=96 | Not yet recruiting | Sponsor: Eli Lilly and Company

New P1 trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus