A Study of LY3305677 in Participants With Obesity Or Overweight

Phase 1

Completed

• Conditions: Overweight; Obesity
• Interventions: Drug: LY3305677; Drug: Placebo

• Registration Number: NCT05623839
• Lead Sponsor: Eli Lilly and Company

Brief Summary

The main purpose of this study is to learn about the safety and tolerability of LY3305677 when given to participants with obesity or overweight. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. Each enrolled participant will receive injections of LY3305677 or placebo given just under the skin. For each participant, the study will last about approximately 28 weeks.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-15
• Study First Submitted QC: 2022-11-15
• Study Start: 2022-11-16
• Study First Posted: 2022-11-21
• Primary Completion: 2023-06-27
• Study Completion: 2023-06-27
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-01
• Last Update Posted: 2023-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Participants who are overtly healthy as determined by medical evaluation
• Participants with stable weight for 3 months and body mass index of 27.0 and 50.0 kilograms per square meter (kg/m²)

Exclusion Criteria

• Have history of type 1 diabetes mellitus or type 2 diabetes mellitus, ketoacidosis, or hyperosmolar state or coma

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LY3305677	LY3305677	LY3305677 administered subcutaneously (SC)
Placebo	Placebo	Placebo administered SC

Primary Outcome Measures

Name	Time	Method
Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	Baseline through Week 20	A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3305677	Predose up to 72 hours postdose	PK: Cmax of LY3305677
PK: Area Under the Concentration Versus Time Curve (AUC) of LY3305677	Predose up to 72 hours postdose	PK: AUC of LY3305677
Pharmacodynamics (PD): Percentage change in Body Weight	Baseline through Week 20	PD: Percentage change in Body Weight

Trial Locations

Locations (3)

ICON Early Phase Services; 🇺🇸 San Antonio, Texas, United States

Anaheim Clinical Trials, LLC; 🇺🇸 Anaheim, California, United States

ICON Early Phase Services Lenexa Center; 🇺🇸 Salt Lake City, Utah, United States