Current partner codePEPTIDESDE
NCT05548231·Phase 1·INTERVENTIONAL

A Study of LY3437943 in Chinese Participants With Obesity Or Overweight

Status

Completed

Phase

Phase 1

Enrollment

32

Locations

2

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

DRUG

LY3437943

Administered SC

DRUG

Placebo

Administered SC

Timeline

From registration to results.

  1. First posted

    Sep 21, 2022

  2. Study start

    Oct 24, 2022

  3. Primary completion

    Jul 27, 2023

  4. Study completion

    Jul 27, 2023

  5. Results posted

    Not reported

  6. Registry updated

    Aug 14, 2023

Outcomes

What the study measures.

Primary outcomes

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

Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3437943

Time frame · Predose through Day 109

PK: Cmax of LY3437943

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

Time frame · Predose through Day 109

PK: AUC of LY3437943

Eligibility

Who can take part.

Minimum age
20 Years
Maximum age
65 Years
Sex
ALL
Healthy volunteers
No

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

Study locations

2 registered sites.

China. Showing up to 24 locations stored in the fast local snapshot.

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Peking University First Hospital

Beijing, China

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

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