A Study of LY3502970 in Healthy Overweight and Obese Participants

Healthy Clinical Trial

Official title:

A Multiple Dose Study in Healthy Overweight and Obese Participants to Investigate the Safety, Tolerability, and Pharmacokinetics of LY3502970

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05313802
• Other study ID #: 18453
• Secondary ID: J2A-MC-GZGK
• Status: Completed
• Phase: Phase 1
• Start date: May 26, 2022
• Est. completion date: September 9, 2022

Study information

• Verified date: October 1, 2022
• 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 evaluate the safety and tolerability of LY3502970 in healthy overweight and obese participants. The blood tests will be conducted to measure how much LY3502970 is in the bloodstream and how the body handles and eliminates LY3502970 in these participants. The study will last up to 42 days excluding the screening period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: September 9, 2022
• Est. primary completion date: September 9, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Participants with stable body weight for at least one month prior to randomization.

• Participants with body mass index (BMI) of greater than or equal to (=) 27.0 kilograms per meter squared (kg/m²)

• Male participants who agree to use highly effective/effective methods of contraception and female participants not of childbearing potential

Exclusion Criteria:

• Have known allergies to LY3502970 or other glucagon-like peptide-1 Receptor Agonists (GLP-1 RA) analogs

• Significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological or neurological disorders

• Have any type of diabetes with hemoglobin A1c (HbA1c) =6.5 %

Related Conditions & MeSH terms

• Healthy
• Obese
• Overweight

Intervention

Drug:
• LY3502970
Administered orally.

Locations

Country	Name	City	State
United States	ICON Early Phase Services Lenexa Center	Lenexa	Kansas
United States	Qps-Mra, Llc	Miami	Florida
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	Predose up to 42 days
Secondary	Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3502970	PK: AUC of LY3502970	Predose up to 29 days postdose
Secondary	PK: Maximum Observed Concentration (Cmax) of LY3502970	PK: Cmax of LY3502970	Predose up to 29 days postdose
Secondary	PK: Time to Maximum Observed Concentration (Tmax) of LY3502970	PK: Tmax of LY3502970	Predose up to 29 days postdose
Secondary	Pharmacodynamics (PD): Change From Baseline in Body Weight	PD: Change From Baseline in Body Weight	Predose through Day 28