DRUG
LY3437943
Administered SC
Status
Completed
Phase
Phase 2
Enrollment
338
Locations
28
Results
Posted
Publications
3
Study summary
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
DRUG
Administered SC
DRUG
Administered SC
Timeline
First posted
May 11, 2021
Study start
May 20, 2021
Primary completion
May 16, 2022
Study completion
Nov 22, 2022
Results posted
Sep 13, 2023
Registry updated
Sep 13, 2023
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.
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
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
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
Publications
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