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Completed

NCT Number: NCT06345066

A Study of LY3841136 in Overweight and Obese Participants

The main purpose of this study is to assess the safety and tolerability of LY3841136 when administered in combination with tirzepatide in overweight and obese patients. The study will last up to approximately 42 weeks.

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Key information

Conditions

Obesity Body Weight 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: No

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

Inclusion criteria

  • Male and female participants who are overtly healthy as determined by medical evaluation
  • Have a stable body weight and Body Mass Index in range of 27 to 45 kilogram per meter square (kg/m²).
  • Have clinical laboratory test results within normal reference range
  • Have venous access sufficient to allow for blood sampling
  • Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures

Exclusion criteria

  • Have type 1 or type 2 diabetes mellitus
  • Have an abnormal 12-lead electrocardiogram (ECG)
  • Have a history or presence of psychiatric disorders
  • Have abnormal blood pressure and pulse rate
  • Are currently enrolled in another clinical study trial involving medical research or have participated within the last 30 days in a clinical study involving an investigational product.

Treatment and study plan

Tirzepatide

Drug

Administered SC.

LY3841136

Drug

Administered SC.

Placebo

Drug

Administered SC.

Primary outcomes

  1. Number of participants with one or more Treatment Emergent Adverse Event(s) (TEAEs) and Serious Adverse Event(s) (SAEs) considered by the investigator to be related to study drug administration

    Time frame: Baseline up to 42 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. Percent change from baseline in body weight

    Time frame: Baseline, Week 42

  2. Pharmacokinetics (PK): Area Under the Concentration versus Time Curve (AUC) of LY3841136

    Time frame: Predose up to 42 weeks

  3. Pharmacokinetics (PK): Maximum plasma concentration (Cmax) of LY3841136

    Time frame: Predose up to 42 weeks

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Multiple Dose Combination Study to Evaluate the Safety and Tolerability of Tirzepatide and LY3841136 in Overweight and Obese Participants

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 3, 2024
Registry last updated
Oct 15, 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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