A Study of LY3305677 in Participants With Obesity Or Overweight

Obesity Clinical Trial

Official title:

A Multiple Dose Titration Study in Participants With Obesity or Overweight to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3305677

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05623839
• Other study ID #: 18522
• Secondary ID: I8P-MC-OXAG
• Status: Completed
• Phase: Phase 1
• Start date: November 16, 2022
• Est. completion date: June 27, 2023

Study information

• Verified date: July 2023
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: June 27, 2023
• Est. primary completion date: June 27, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Drug:
• LY3305677
Administered SC
• Placebo
Administered SC

Locations

Country	Name	City	State
United States	Anaheim Clinical Trials, LLC	Anaheim	California
United States	ICON Early Phase Services Lenexa Center	Salt Lake City	Utah
United States	ICON Early Phase Services	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module	Baseline through Week 20
Secondary	Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3305677	PK: Cmax of LY3305677	Predose up to 72 hours postdose
Secondary	PK: Area Under the Concentration Versus Time Curve (AUC) of LY3305677	PK: AUC of LY3305677	Predose up to 72 hours postdose
Secondary	Pharmacodynamics (PD): Percentage change in Body Weight	PD: Percentage change in Body Weight	Baseline through Week 20