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A Study of LY3437943 in Chinese Participants With Obesity Or Overweight

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Status and phase

Completed
Phase 1

Conditions

Overweight
Obesity

Treatments

Drug: LY3437943
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT05548231
J1I-MC-GZBE (Other Identifier)
17954

Details and patient eligibility

About

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.

Enrollment

32 patients

Sex

All

Ages

20 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

Double Blind

32 participants in 2 patient groups, including a placebo group

LY3437943
Experimental group
Description:
LY3437943 administered subcutaneously (SC)
Treatment:
Drug: LY3437943
Placebo
Placebo Comparator group
Description:
Placebo administered SC
Treatment:
Drug: Placebo

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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