Current partner codePEPTIDESDE
NCT04881760·Phase 2·INTERVENTIONAL

A Study of LY3437943 in Participants Who Have Obesity or Are Overweight

Status

Completed

Phase

Phase 2

Enrollment

338

Locations

28

Results

Posted

Publications

3

Study summary

What the protocol is testing.

This is a study of LY3437943 in participants who have obesity or are overweight. The main purpose is to learn more about how LY3437943 affects body weight loss. The study will last about 18 months and may include up to 18 visits.

Interventions

Treatment arms and agents.

DRUG

LY3437943

Administered SC

DRUG

Placebo

Administered SC

Timeline

From registration to results.

  1. First posted

    May 11, 2021

  2. Study start

    May 20, 2021

  3. Primary completion

    May 16, 2022

  4. Study completion

    Nov 22, 2022

  5. Results posted

    Sep 13, 2023

  6. Registry updated

    Sep 13, 2023

Outcomes

What the study measures.

Primary outcomes

Mean Percent Change From Baseline in Body Weight

Time frame · Baseline, Week 24

Least squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) for post-baseline measures: Variable = Treatment\*Time + Baseline BMI (\< 36kg/m2 vs. \>=36 kg/m2)\*Time + Sex (Female vs. Male)\*Time + Baseline\*Time.

Secondary outcomes

Mean Percent Change From Baseline in Body Weight

Time frame · Baseline, Week 48

LS means were calculated using a MMRM model for post-baseline measures: Variable = Treatment\*Time + Baseline BMI (\< 36kg/m2 vs. \>=36 kg/m2)\*Time + Sex (Female vs. Male)\*Time + Baseline\*Time.

Percentage of Participants Who Achieve ≥ 5% Body Weight Reduction

Time frame · Week 24

Percentage of participants who achieve ≥ 5% body weight reduction in LY3437943 relative to placebo. Estimated percentage was determined by logistic regression model with an intercept term, treatment group, baseline BMI stratum \[\<36 kilograms per square meter (kg/m2), ≥36 kg/m2\] and sex \[female, male\] as fixed effects, and baseline body weight as a covariate.

Percentage of Participants Who Achieve ≥ 5% Body Weight Reduction

Time frame · Week 48

Percentage of participants who achieve ≥ 5% body weight reduction in LY3437943 relative to placebo. Estimated percentage was determined by logistic regression model with an intercept term, treatment group, baseline BMI stratum \[\<36 kg/m2, ≥36 kg/m2\] and sex \[female, male\] as fixed effects, and baseline body weight as a covariate.

Percentage of Participants Who Achieve ≥ 10% Body Weight Reduction

Time frame · Week 24

Percentage of participants who achieve ≥ 10% body weight reduction in LY3437943 relative to placebo. Estimated percentage was determined by logistic regression model with an intercept term, treatment group, baseline BMI stratum \[\<36 kg/m2, ≥36 kg/m2\] and sex \[female, male\] as fixed effects, and baseline body weight as a covariate.

Percentage of Participants Who Achieve ≥ 10% Body Weight Reduction

Time frame · Week 48

Percentage of participants who achieve ≥ 10% body weight reduction in LY3437943 relative to placebo. Estimated percentage was determined by logistic regression model with an intercept term, treatment group, baseline BMI stratum \[\<36 kg/m2, ≥36 kg/m2\] and sex \[female, male\] as fixed effects, and baseline body weight as a covariate.

Percentage of Participants Who Achieve ≥ 15% Body Weight Reduction

Time frame · Week 24

Percentage of participants who achieve ≥ 15% body weight reduction in LY3437943 relative to placebo. Estimated percentage was determined by logistic regression model with an intercept term, treatment group, baseline BMI stratum \[\<36 kg/m2, ≥36 kg/m2\] and sex \[female, male\] as fixed effects, and baseline body weight as a covariate.

Percentage of Participants Who Achieve ≥ 15% Body Weight Reduction

Time frame · Week 48

Percentage of participants who achieve ≥ 15% body weight reduction in LY3437943 relative to placebo. Estimated percentage was determined by logistic regression model with an intercept term, treatment group, baseline BMI stratum \[\<36 kg/m2, ≥36 kg/m2\] and sex \[female, male\] as fixed effects, and baseline body weight as a covariate.

Mean Change From Baseline in Body Weight

Time frame · Baseline, Week 24

LS means were calculated using a MMRM model for post-baseline measures: Variable = Treatment\*Time + Baseline BMI (\< 36kg/m2 vs. \>=36 kg/m2)\*Time + Sex (Female vs. Male)\*Time + Baseline\*Time.

Mean Change From Baseline in Body Weight

Time frame · Baseline, Week 48

LS means were calculated using a MMRM model for post-baseline measures: Variable = Treatment\*Time + Baseline BMI (\< 36kg/m2 vs. \>=36 kg/m2)\*Time + Sex (Female vs. Male)\*Time + Baseline\*Time.

Mean Change From Baseline in BMI

Time frame · Baseline, Week 24

LS means were calculated using a MMRM model for post-baseline measures: Variable = Treatment\*Time + Baseline BMI (\< 36kg/m2 vs. \>=36 kg/m2)\*Time + Sex (Female vs. Male)\*Time + Baseline\*Time.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
75 Years
Sex
ALL
Healthy volunteers
No

Inclusion Criteria: * Participants must have a Body Mass Index (BMI) ) ≥30 and ≤50 kilograms per square meter (kg/m²), or ≥27 kg/m² and \<30 kg/m², with at least one of the following comorbidities: hypertension, dyslipidemia, cardiovascular disease * Participants must be willing to learn how to self-inject study drug or receive an injection from a trained individual if visually impaired or with physical limitations, and follow study procedures for the duration of the study, including, but not limited to, follow lifestyle advice (for example, dietary changes and physical activity plan), maintain a study drug administration log, and complete required questionnaires Exclusion Criteria: * Participants must not have type 1 or type 2 diabetes mellitus * Participants must not have had an increase or decrease in body weight \> more than 5 kg (11 pounds) within the past 3 months * Participants must not have had surgery for obesity or plan to have such surgery during the study * Participants must not be using medications that promote weight loss or cause weight gain * Participants must not drink excessive amounts of alcohol (more than 14 units a week for women or more than 21 units a week for men) * Participants must not have used marijuana within the last 3 months. * Participants must not have heart attack, stroke, or hospitalization for congestive heart failure in the past 3 months * Participants must not have active cancer within the last 5 years * Participants must not have uncontrolled high blood pressure * Participants must not have liver disease other than non-alcoholic fatty liver disease * Participants must not have renal impairment with estimated glomerular filtration rate (eGFR) \<45 mL/min/1.73 m2 * Participants must not have a history of acute or chronic pancreatitis symptomatic gallbladder disease or documented human immunodeficiency virus infection * Participants must not have a major problem with depression or other mental illness within the last 2 years * Participants must not have family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma (family is defined as a first degree relative) * Female participants must not be pregnant, breast-feeding, or intend to become pregnant or of childbearing potential and not using adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice)

Study locations

28 registered sites.

Puerto Rico · United States. Showing up to 24 locations stored in the fast local snapshot.

Perseverance Research Center

Scottsdale, Arizona, United States

Anaheim Clinical Trials, LLC

Anaheim, California, United States

Valley Research

Fresno, California, United States

Velocity Clinical Research, Huntington Park

Huntington Park, California, United States

Velocity Clinical Research, Huntington Park

Los Angeles, California, United States

Southern California Dermatology, Inc.

Santa Ana, California, United States

Coastal Metabolic Research Centre

Ventura, California, United States

Diablo Clinical Research, Inc.

Walnut Creek, California, United States

East Coast Institute for Research, LLC

Jacksonville, Florida, United States

Suncoast Clinical Research, Inc.

New Port Richey, Florida, United States

Encore Medical Research - Weston

Weston, Florida, United States

Springfield Diabetes & Endocrine Center

Springfield, Illinois, United States

Cotton O'Neil Diabetes and Endocrinology Center

Topeka, Kansas, United States

Tandem Clinical Research,LLC

Marrero, Louisiana, United States

StudyMetrix Research

City of Saint Peters, Missouri, United States

Amici Clinical Research LLC

Raritan, New Jersey, United States

Intend Research, LLC

Norman, Oklahoma, United States

Allegheny Endocrinology Associates

Pittsburgh, Pennsylvania, United States

New Phase Research and Development

Knoxville, Tennessee, United States

Texas Diabetes & Endocrinology, P.A.

Austin, Texas, United States

Dallas Diabetes Research Center

Dallas, Texas, United States

Juno Research

Houston, Texas, United States

Endocrine Ips, Pllc

Houston, Texas, United States

Southern Endocrinology Associates

Mesquite, Texas, United States

Related trials

More studies on Retatrutide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.