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Completed

NCT Number: NCT05295940

A Study of LY3841136 in Healthy and Overweight Participants

The main purpose of this study is to evaluate the safety and tolerability of LY3841136 in healthy and overweight participants. Blood tests will be performed to check how much LY3841136 gets into the bloodstream and how long it takes the body to eliminate it. This is a 2-part study and may last up to 14 and 28 weeks for each participant and may include 7 and 19 visits in parts A and B, respectively.

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Key information

Conditions

Obesity Body Weight Healthy Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Fortrea Clinical Research Unit, Daytona Beach, Florida, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male participants who agree to use highly effective/effective methods of contraception and female participants not of childbearing potential
  • Have had a stable weight for the last 3 months
  • Have a body mass index (BMI) in the range of 18.5 to 32 kilogram per square meter (kg/m²), both inclusive (in Part A) or a BMI in the range of 27 to 40 kg/m², both inclusive (in Part B)

Exclusion criteria

  • Are women who are lactating
  • Have known allergies to related compounds of LY3841136 or any components of the formulation
  • Have a history of significant atopy (severe or multiple allergic manifestations), or clinically significant multiple or severe drug allergies, or severe posttreatment hypersensitivity reactions
  • Have been diagnosed with Type 1 or Type 2 diabetes mellitus
  • Have a history of chronic medical conditions involving the heart, liver, or kidneys

Treatment and study plan

LY3841136

Drug

Administered SC.

Placebo

Drug

Administered SC.

Primary outcomes

  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

    Time frame: Predose up to 14 weeks (Part A) & 28 weeks (Part B)

    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 outcomes

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

    Time frame: Predose through week 14 (Part A) & week 28 (Part B)

    PK: AUC of LY3841136

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

    Time frame: Predose through week 14 (Part A) & week 28 (Part B)

    PK: Cmax of LY3841136

  3. Pharmacodynamics (PD): Change From Baseline in Body Weight

    Time frame: Predose through week 28

    PD: Change From Baseline in Body Weight

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3841136 in Healthy and Overweight Participants

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 25, 2022
Registry last updated
Apr 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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