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Clinical Trials/NCT06297616
NCT06297616CompletedPhase 1

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

Eli Lilly and Company3 sites in 1 country128 target enrollmentStarted: April 15, 2024Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
128
Locations
3
Primary Endpoint
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

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Arms & Interventions

Part B: LY3841136 + Tirzepatide-Placebo

Experimental

LY3841136 administered SC along with volume-matched Tirzepatide-Placebo administered SC

Intervention: Tirzepatide-Placebo (Drug)

Part A: LY3841136

Experimental

LY3841136 administered subcutaneously (SC)

Intervention: LY3841136 (Drug)

Part A: Placebo

Placebo Comparator

Placebo administered SC

Intervention: LY3841136-Placebo (Drug)

Part B: Tirzepatide + LY3841136-Placebo

Experimental

Tirzepatide administered SC along with volume-matched LY3841136-Placebo administered SC

Intervention: LY3841136-Placebo (Drug)

Part B: Tirzepatide + LY3841136-Placebo

Experimental

Tirzepatide administered SC along with volume-matched LY3841136-Placebo administered SC

Intervention: Tirzepatide (Drug)

Part B: LY3841136 + Tirzepatide-Placebo

Experimental

LY3841136 administered SC along with volume-matched Tirzepatide-Placebo administered SC

Intervention: LY3841136 (Drug)

Part B: LY3841136 + Tirzepatide

Experimental

LY3841136 administered SC along with Tirzepatide administered SC

Intervention: LY3841136 (Drug)

Part B: LY3841136 + Tirzepatide

Experimental

LY3841136 administered SC along with Tirzepatide administered SC

Intervention: Tirzepatide (Drug)

Part B: LY3841136-Placebo + Tirzepatide-Placebo

Placebo Comparator

Volume-matched LY3841136-Placebo administered SC along with volume-matched Tirzepatide-Placebo administered SC

Intervention: LY3841136-Placebo (Drug)

Part B: LY3841136-Placebo + Tirzepatide-Placebo

Placebo Comparator

Volume-matched LY3841136-Placebo administered SC along with volume-matched Tirzepatide-Placebo administered SC

Intervention: Tirzepatide-Placebo (Drug)

Outcomes

Primary Outcomes

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

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

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

Time Frame: 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

Secondary Outcomes

  • Part A Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3841136(Predose through Week 22)
  • Part A PK: Maximum Observed Concentration (Cmax) of LY3841136(Predose through Week 22)
  • Part A Pharmacodynamics (PD): Change From Baseline in Body Weight at Week 12(Baseline through Week 12)
  • Part B PK: AUC of LY3841136 in Combination with Tirzepatide(Predose through Week 34)
  • Part B PK: Cmax of LY3841136 in Combination with Tirzepatide(Predose through Week 34)
  • Part B PD: Change From Baseline in Body Weight at Week 24(Baseline through Week 24)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (3)

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