A Study of LY3841136 in Japanese Participants With Obesity or Overweight

NCT06297616
clinicaltrials.gov
Phase
Phase 1
clinicaltrials.gov
Recruitment status
Completed
clinicaltrials.gov
Participants
128
clinicaltrials.gov
Lead sponsor
Eli Lilly and Company
clinicaltrials.gov
Start date
2024-04-15
clinicaltrials.gov
Number of sites
3
clinicaltrials.gov

Summary
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.
clinicaltrials.gov
Short title
A Study of LY3841136 in Japanese Participants With Obesity or Overweight
clinicaltrials.gov
Official title
A Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3841136 Monotherapy, and LY3841136 in Combination With Tirzepatide, in Japanese Participants With Obesity or Overweight
clinicaltrials.gov

Control arm
Placebo
clinicaltrials.gov
Registry reports results
No
clinicaltrials.gov
Listing at source
Listed
clinicaltrials.gov
Recruitment status
Completed
clinicaltrials.gov
Phase
Phase 1
clinicaltrials.gov
Study type
Interventional
clinicaltrials.gov

Completion date
2025-11-21
clinicaltrials.gov
First posted
2024-03-07
clinicaltrials.gov
Registry last updated
2026-01-16
clinicaltrials.gov
Primary completion date
2025-11-21
clinicaltrials.gov
Start date
2024-04-15
clinicaltrials.gov

Actual participants
128
clinicaltrials.gov
Participants
128
clinicaltrials.gov
Participant count basis
Actual
clinicaltrials.gov
Protocol amendments
2
clinicaltrials.gov
Number of sites
3
clinicaltrials.gov

Data monitoring committee
No
clinicaltrials.gov
Registry sponsor category
Industry
clinicaltrials.gov
Lead sponsor
Eli Lilly and Company
clinicaltrials.gov
Source registry
ClinicalTrials.gov
clinicaltrials.gov

Registry ID
NCT06297616
clinicaltrials.gov
ClinicalTrials.gov ID
NCT06297616
clinicaltrials.gov
Registry record
Open registry record
clinicaltrials.gov

Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Double masking
Masked roles
Participants, Investigators
Sources for study design
clinicaltrials.gov

  1. 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

    Timeframe: Baseline through Week 22

    A summary of treatment emergent adverse events (TEAEs), SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

  2. Part B: Number of Participants with One or More Serious Adverse Events (SAE) Considered by the Investigator to be Related to Study Drug Administration at Week 34

    Timeframe: Baseline through Week 34

    A summary of treatment emergent adverse events (TEAEs), SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

  1. Part A Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3841136

    Timeframe: Predose through Week 22

    PK: AUC of LY3841136 alone

  2. Part A PK: Maximum Observed Concentration (Cmax) of LY3841136

    Timeframe: Predose through Week 22

    PK: Cmax of LY3841136 alone

  3. Part A Pharmacodynamics (PD): Change From Baseline in Body Weight at Week 12

    Timeframe: Baseline through Week 12

    PD: Change from baseline in body weight

  4. Part B PK: AUC of LY3841136 in Combination with Tirzepatide

    Timeframe: Predose through Week 34

    PK: AUC of LY3841136 in combination with tirzepatide

  5. Part B PK: Cmax of LY3841136 in Combination with Tirzepatide

    Timeframe: Predose through Week 34

    PK: Cmax of LY3841136 in combination with tirzepatide

  6. Part B PD: Change From Baseline in Body Weight at Week 24

    Timeframe: Baseline through Week 24

    PD: Change from baseline in body weight

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
65 Years
Healthy volunteers
No

  • Male or female participants who agree to contraception requirements
  • Have a body mass index (BMI) within the range of 27 to 40 kg/m², inclusive
  • Have had a stable weight for the 3 months

  • Have a history of significant atopy (severe allergic manifestations), multiple or severe drug allergies, or severe posttreatment hypersensitivity reactions
  • Have a history or presence of psychiatric disorders, including a history of major depressive disorder or severe psychiatric disorders such as schizophrenia, bipolar disorder within the last 3 years
  • Have been diagnosed with Type 1 or Type 2 Diabetes Mellitus
  • Have a history of chronic medical conditions involving the heart, liver, or kidneys
  • Have a history of any malignancy within the past 5 years
  • Have a history or presence of a GI disorder
  • Have had within the last 6 months, or plan to have during the study, a device-based or surgical treatment use for obesity
  • Have been treated, or plan to be treated, with prescription medications or other non-approved drugs intended to promote weight loss, within 3 months prior to screening
  • For participants in Part B, have previously received tirzepatide within 6 months prior to screening
  • For participants in Part B, have a personal or family history of medullary thyroid carcinoma, or have multiple endocrine neoplasia syndrome type 2
Sources for eligibility
clinicaltrials.gov

  • P-One ClinicHachiōji, Japan
  • Sumida HospitalSumida-ku, Japan
  • Hakata ClinicFukuoka, Japan
Sources for sites
clinicaltrials.gov

Other registry identifiers

  • J3R-JE-YDAB
Sources for references
clinicaltrials.gov

Related records

Drugs (2)

Lead sponsors (1)

Conditions (2)

Targets (2)