A Study of LY3841136 in Japanese Participants With Obesity or Overweight

Sponsor
Eli Lilly and Company
Study ID
NCT06297616
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • LY3841136 — DRUG
    Administered SC
  • LY3841136-Placebo — DRUG
    Administered SC
  • Tirzepatide — DRUG
    Administered SC
  • Tirzepatide-Placebo — DRUG
    Administered SC

Study Details

The main purpose of this study is to learn about the side effects of LY3841136 alone and in combination with tirzepatide, when given to Japanese participants with obese or overweight. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. Part A of the study will last about 28 weeks and may include up to 17 visits. Part B of the study will last about 40 weeks and may include up to 29 visits.

Key Dates

Start date
Apr 15, 2024
Status verified
Jan 2026
Primary completion
Nov 21, 2025
Completion
Nov 21, 2025

Study Design

Enrollment
128 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A: LY3841136
    LY3841136 administered subcutaneously (SC)
  • Placebo Comparator: Part A: Placebo
    Placebo administered SC
  • Experimental: Part B: Tirzepatide + LY3841136-Placebo
    Tirzepatide administered SC along with volume-matched LY3841136-Placebo administered SC
  • Experimental: Part B: LY3841136 + Tirzepatide-Placebo
    LY3841136 administered SC along with volume-matched Tirzepatide-Placebo administered SC
  • Experimental: Part B: LY3841136 + Tirzepatide
    LY3841136 administered SC along with Tirzepatide administered SC
  • Placebo Comparator: Part B: LY3841136-Placebo + Tirzepatide-Placebo
    Volume-matched LY3841136-Placebo administered SC along with volume-matched Tirzepatide-Placebo administered SC

Primary Outcome Measure

Part A: Number of Participants with One or More Serious Adverse Events (SAE) Considered by the Investigator to be Related to Study Drug Administration at Week 22 [ Time Frame: Baseline through Week 22 ]

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