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A Study of LY3502970 in Healthy Overweight and Obese Participants

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05313802
Collaborator
(none)
72
Enrollment
3
Locations
3
Arms
3.5
Anticipated Duration (Months)
24
Patients Per Site
6.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
72 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Basic Science
Official Title:
A Multiple Dose Study in Healthy Overweight and Obese Participants to Investigate the Safety, Tolerability, and Pharmacokinetics of LY3502970
Actual Study Start Date :
May 26, 2022
Anticipated Primary Completion Date :
Sep 9, 2022
Anticipated Study Completion Date :
Sep 9, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: LY3502970 (Dose Level 1)

LY3502970 administered orally.

Drug: LY3502970
Administered orally.
Experimental: LY3502970 (Dose Level 2)

LY3502970 administered orally.

Drug: LY3502970
Administered orally.
Experimental: LY3502970 (Dose Level 3)

LY3502970 administered orally.

Drug: LY3502970
Administered orally.

Outcome Measures

Primary Outcome Measures

  1. 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 [Predose 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

  1. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3502970 [Predose up to 29 days postdose]

    PK: AUC of LY3502970

  2. PK: Maximum Observed Concentration (Cmax) of LY3502970 [Predose up to 29 days postdose]

    PK: Cmax of LY3502970

  3. PK: Time to Maximum Observed Concentration (Tmax) of LY3502970 [Predose up to 29 days postdose]

    PK: Tmax of LY3502970

  4. Pharmacodynamics (PD): Change From Baseline in Body Weight [Predose through Day 28]

    PD: Change From Baseline in Body Weight

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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 %

Contacts and Locations

Locations

Site City State Country Postal Code
1 Qps-Mra, Llc Miami Florida United States 33143
2 ICON Early Phase Services Lenexa Center Lenexa Kansas United States 66219
3 ICON Early Phase Services San Antonio Texas United States 78209

Sponsors and Collaborators

  • Eli Lilly and Company

Investigators

  • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT05313802
Other Study ID Numbers:
  • 18453
  • J2A-MC-GZGK
First Posted:
Apr 6, 2022
Last Update Posted:
Aug 18, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Eli Lilly and Company
Pharmacokinetics
Safety and Tolerability
LY3502970
Additional relevant MeSH terms:
Overweight

Study Results

No Results Posted as of Aug 18, 2022