NCT05548231

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 16, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 21, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

October 24, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 27, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 27, 2023

Completed
Last Updated

August 14, 2023

Status Verified

August 1, 2023

Enrollment Period

9 months

First QC Date

September 16, 2022

Last Update Submit

August 10, 2023

Conditions

OverweightObesity

Outcome Measures

Primary Outcomes (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

    A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

    Baseline through Week 20

Secondary Outcomes (2)

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

    Predose through Day 109

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

    Predose through Day 109

Study Arms (2)

LY3437943

EXPERIMENTAL

LY3437943 administered subcutaneously (SC)

Drug: LY3437943

Placebo

PLACEBO COMPARATOR

Placebo administered SC

Drug: Placebo

Interventions

LY3437943DRUG

Administered SC

LY3437943
PlaceboDRUG

Administered SC

Placebo

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

Location

Peking University First Hospital

Beijing, 100034, China

Location

MeSH Terms

Conditions

OverweightObesity

Interventions

retatrutide

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • 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 DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2022

First Posted

September 21, 2022

Study Start

October 24, 2022

Primary Completion

July 27, 2023

Study Completion

July 27, 2023

Last Updated

August 14, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)