Clinical trial NCT05548231: A Study of LY3437943 in Chinese Participants With Obesity Or Overweight
Official title: A Multiple Dose Escalation Study in Chinese Participants With Overweight BMI or Obesity to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3437943
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Overweight
Obesity
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2022-09-21
Enrollment: 32
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Baseline through Week 20
Secondary outcomes:
measure: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3437943
timeFrame: Predose through Day 109
measure: PK: Area Under the Concentration Versus Time Curve (AUC) of LY3437943
timeFrame: Predose through Day 109
Other outcomes:
Locations:
city: Cheng Du
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Beijing
country: China
facility: Peking University First Hospital
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: