A Study of LY3437943 in Chinese Participants With Obesity Or Overweight

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05548231
Collaborator
(none)
32
2
2
8
16
2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
32 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Basic Science
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
Anticipated Study Start Date :
Oct 15, 2022
Anticipated Primary Completion Date :
Jun 15, 2023
Anticipated Study Completion Date :
Jun 15, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: LY3437943

LY3437943 administered subcutaneously (SC)

Drug: LY3437943
Administered SC

Placebo Comparator: Placebo

Placebo administered SC

Drug: Placebo
Administered SC

Outcome Measures

Primary Outcome Measures

  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 [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 Outcome Measures

  1. Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3437943 [Predose through Day 109]

    PK: Cmax of LY3437943

  2. PK: Area Under the Concentration Versus Time Curve (AUC) of LY3437943 [Predose through Day 109]

    PK: AUC of LY3437943

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 65 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 West China Hospital of Sichuan University Cheng Du Sichuan China 610041
2 Peking University First Hospital Beijing China 100034

Sponsors and Collaborators

  • Eli Lilly and Company

Investigators

  • Study Director: 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), Eli Lilly and Company

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT05548231
Other Study ID Numbers:
  • 17954
  • J1I-MC-GZBE
First Posted:
Sep 21, 2022
Last Update Posted:
Sep 21, 2022
Last Verified:
Sep 15, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 21, 2022