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A Study of LY3502970 in Healthy Overweight and Obese Participants

Phase 1
Completed
Conditions
Healthy
Obese
Interventions
Registration Number
NCT05313802
Lead Sponsor
Eli Lilly and Company
Brief 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
72
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 %

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
LY3502970 (Dose Level 2)LY3502970LY3502970 administered orally.
LY3502970 (Dose Level 1)LY3502970LY3502970 administered orally.
LY3502970 (Dose Level 3)LY3502970LY3502970 administered orally.
Primary Outcome Measures
NameTimeMethod
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 AdministrationPredose up to 42 days

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
NameTimeMethod
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3502970Predose up to 29 days postdose

PK: AUC of LY3502970

PK: Maximum Observed Concentration (Cmax) of LY3502970Predose up to 29 days postdose

PK: Cmax of LY3502970

Pharmacodynamics (PD): Change From Baseline in Body WeightPredose through Day 28

PD: Change From Baseline in Body Weight

PK: Time to Maximum Observed Concentration (Tmax) of LY3502970Predose up to 29 days postdose

PK: Tmax of LY3502970

Trial Locations

Locations (3)

ICON Early Phase Services

🇺🇸

San Antonio, Texas, United States

Qps-Mra, Llc

🇺🇸

Miami, Florida, United States

ICON Early Phase Services Lenexa Center

🇺🇸

Lenexa, Kansas, United States

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