A Study of LY3841136 in Japanese Participants With Obesity or Overweight

Obesity Clinical Trial

Official title:

A Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3841136 in Japanese Participants With Obesity or Overweight

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06297616
• Other study ID #: 18814
• Secondary ID: J3R-JE-YDAB
• Status: Recruiting
• Phase: Phase 1
• Start date: April 15, 2024
• Est. completion date: December 2025

Study information

• Verified date: May 2024
• Source: Eli Lilly and Company
• Contact: There may be multiple sites in this clinical trial. 1-877-CTLILL
• Phone: 1-317-615-4559
• Email: ClinicalTrials.gov[@]lilly.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main purpose of this study is to learn about the side effects of LY3841136 when given to Japanese participants with obese or overweight. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. The study will last about 28 weeks and may include up to 17 visits.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Male or female participants who agree to contraception requirements

• Have a body mass index (BMI) within the range of 27 to 40 kg/m², inclusive

• Have had a stable weight for the 3 months

Exclusion Criteria:

• Have a history of significant atopy (severe allergic manifestations), multiple or severe drug allergies, or severe posttreatment hypersensitivity reactions

• Have a history or presence of psychiatric disorders, including a history of major depressive disorder or severe psychiatric disorders such as schizophrenia, bipolar disorder within the last 3 years

• Have been diagnosed with Type 1 or Type 2 Diabetes Mellitus

• Have a history of chronic medical conditions involving the heart, liver, or kidneys

• Have a history of any malignancy within the past 5 years

• Have a history or presence of a GI disorder

• Have had within the last 6 months, or plan to have during the study, a device-based or surgical treatment use for obesity

• Have been treated, or plan to be treated, with prescription medications or other non-approved drugs intended to promote weight loss, within 3 months prior to screening

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Drug:
• LY3841136
Administered SC
• Placebo
Administered SC

Locations

Country	Name	City	State
Japan	Hakata Clinic	Fukuoka
Japan	Sumida Hospital	Sumida-ku	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with One or More Serious Adverse Events (SAE) Considered by the Investigator to be Related to Study Drug Administration	A summary of treatment emergent adverse events (TEAEs), SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module	Baseline through Week 22
Secondary	Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3841136	PK: AUC of LY3841136	Predose through Week 22
Secondary	PK: Maximum Observed Concentration (Cmax) of LY3841136	PK: Cmax of LY3841136	Predose through Week 22
Secondary	Pharmacodynamics (PD): Change From Baseline in Body Weight	PD: Change from baseline in body weight	Baseline through Week 12

External Links

•   A Study of LY3841136 in Japanese Participants with Obesity or Overweight