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Completed

NCT Number: NCT05380323

A Study of LY3541105 in Healthy and Overweight Participants

The main purpose of this study is to evaluate the safety and tolerability of LY3541105 in healthy and overweight participants. Blood tests will be performed to check how much LY3541105 gets into the bloodstream and how long it takes the body to eliminate it. The study will also evaluate the effects of LY3541105 on body weight and assess safety and tolerability of LY3541105. This is a 3-part study and may last up to 15, 26 and 24 weeks for each participant and may include up to 7, 15 and 16 visits in parts A, B and C, respectively.

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Key information

Conditions

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

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PRA International, Lenexa, Kansas, 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

  • Participants who are overtly healthy as determined by medical evaluation
  • Male participants who agree to refrain from sperm donation and to use contraceptive methods and female participants not of childbearing potential
  • Have a body mass index (BMI) in the range of greater than or equal to (>/=) 18.5 to less than (<) 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 and C)
  • Have had a stable weight for the last 3 months

Exclusion criteria

  • Have history of diabetes (except gestational diabetes) or current diagnosis of diabetes
  • Clinically significant abnormal electrocardiogram (ECG) at screening, as judged by the Investigator
  • Have history or current evidence of a clinically significant cardiovascular condition

Treatment and study plan

LY3541105

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 26 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 outcomes

  1. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3541105

    Time frame: Predose through day 43 (Part A) & day 78 (Part B)

    PK: AUC of LY3541105

  2. PK: Time of Maximum observed Concentration (Tmax) of LY3541105

    Time frame: Predose through day 43 (Part A) & day 78 (Part B)

    PK: Tmax of LY3541105

  3. PK: Maximum Observed Concentration (Cmax) of LY3541105

    Time frame: Predose through day 43 (Part A) & day 78 (Part B)

    PK: Cmax of LY3541105

  4. Pharmacodynamics (PD): Absolute and Percentage Change from Baseline in Body Weight

    Time frame: Predose through week 26 (Part B Only)

    PD: Absolute and Percentage Change from Baseline in Body Weight

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Phase 1, Randomized, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability, and PK of LY3541105 Following Single Doses in Healthy/Overweight Participants and Multiple Doses in Overweight Participants

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
May 18, 2022
Registry last updated
Jun 27, 2025

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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