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NCT Number: NCT05548231

A Study of LY3437943 in Chinese Participants With Obesity Or Overweight

The main purpose of this study is to learn about the safety and tolerability of LY3437943 when given to Chinese participants with overweight body mass index (BMI) or obesity. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. Each enrolled participant will receive injections of LY3437943 or placebo given just under the skin. For each participant, the study will last about 20 weeks excluding screening period and may include up to 20 visits to the study center.

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Key information

Conditions

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

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

West China Hospital of Sichuan University, Chengdu, Sichuan, China

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

For All Participants:

  • Are native Chinese males or females
  • Have a body mass index of ≥27 and ≤40 kilograms per square meter (kg/m²)
  • Have not modified diet or adopted any nutritional lifestyle modification for 3 months
  • Have stable body weight for the last three months
  • Male participants must agree to use contraception during the study and for 4 months afterward and female participants must be woman of nonchildbearing potential

For Type 2 Diabetes Mellitus (T2DM) Participants:

  • Have type 2 diabetes for at least 3 months
  • Have a glycated hemoglobin (HbA1c) value of ≥7.0% and ≤10.5% and have been treated with diet and exercise alone or a stable dose of metformin for at least 3 months prior to screening

Exclusion criteria

For All Participants:

  • Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week and smoke more than 10 cigarettes, or cigarette equivalent (as determined by investigator), per day
  • Have other serious or unstable illnesses
  • Have had an episode of severe hypoglycemia
  • Current or chronic history of liver disease.

For T2DM Participants:

  • Have type 1 diabetes mellitus
  • Have uncontrolled diabetes, defined as an episode of ketoacidosis or hyperosmolar state requiring hospitalization
  • Any glucose-lowering medications other than metformin within 3 months prior to screening

Treatment and study plan

LY3437943

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: Baseline through Week 20

    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): Maximum Concentration (Cmax) of LY3437943

    Time frame: Predose through Day 109

    PK: Cmax of LY3437943

  2. PK: Area Under the Concentration Versus Time Curve (AUC) of LY3437943

    Time frame: Predose through Day 109

    PK: AUC of LY3437943

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Multiple Dose Escalation Study in Chinese Participants With Overweight BMI or Obesity to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3437943

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 21, 2022
Registry last updated
Aug 14, 2023

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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