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A Study of LY3457263 in Obese Participants

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05582096
Collaborator
(none)
45
Enrollment
1
Location
2
Arms
5.6
Anticipated Duration (Months)
8
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 LY3457263 when administered in combination with tirzepatitide in overweight or obese participants. The study will also evaluate how much of LY3457263 gets into the blood stream and how long it takes the body to remove it in overweight or obese participants. The study will last up to approximately 11 weeks.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
45 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Basic Science
Official Title:
A Dose-Escalation Treatment, Phase 1, Investigator- and Participant-Blind, Placebo-controlled Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of LY3457263 in Combination With Tirzepatide in Overweight or Obese Participants
Actual Study Start Date :
Nov 11, 2022
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: LY3457263 + Tirzepatide

LY3457263 administered subcutaneously (SC) in combination with tirzepatide given SC.

Drug: LY3457263
Administered SC.

Drug: Tirzepatide
Administered SC.
Other Names:
  • LY3298176

    		•
    Placebo Comparator: Placebo + Tirzepatide

    Placebo administered SC in combination with tirzepatide given SC.

    Drug: Tirzepatide
    Administered SC.
    Other Names:
  • LY3298176

    • Drug: Placebo
    Administered SC.

    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 [Baseline up to 11 weeks]

      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 LY3457263 [Predose on Day 1 up to 43 days postdose]

      PK: AUC of LY3457263

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Participants who are overtly healthy as determined by medical evaluation

    • Have a stable body weight and body mass index (BMI) within the range 27.0 to 45.0 kilograms per meter squared (kg/m²)

    • Male or female participants not of childbearing potential

    Exclusion Criteria:

    • Have a mean sitting systolic blood pressure (BP) higher than 160 millimeters of mercury (mmHg) or a mean sitting diastolic BP higher than 90 mmHg from 3 measurements

    • Have an abnormal 12-lead electrocardiogram (ECG) at screening

    • Have type 1 or type 2 diabetes mellitus

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 LabCorp CRU, Inc. Daytona Beach Florida United States 32117

    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:
    NCT05582096
    Other Study ID Numbers:
    • 18463
    • J1R-MC-GZFC
    First Posted:
    Oct 17, 2022
    Last Update Posted:
    Dec 9, 2022
    Last Verified:
    Dec 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
    Additional relevant MeSH terms:
    Overweight
    Tirzepatide

    Study Results

    No Results Posted as of Dec 9, 2022