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

Obesity Clinical Trial

Official title:

A Phase 2 Study of Once-Weekly LY3437943 Compared With Placebo in Participants Who Have Obesity or Are Overweight With Weight-Related Comorbidities

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04881760
• Other study ID #: 18122
• Secondary ID: J1I-MC-GZBF
• Status: Completed
• Phase: Phase 2
• Start date: May 20, 2021
• Est. completion date: November 22, 2022

Study information

• Verified date: August 2023
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 338
• Est. completion date: November 22, 2022
• Est. primary completion date: May 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

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)

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Drug:
• LY3437943
Administered SC
• Placebo
Administered SC

Locations

Country	Name	City	State
Puerto Rico	Private Practice - Dr. Paola Mansilla-Letelier	Guaynabo
Puerto Rico	GCM Medical Group, PSC - Hato Rey Site	San Juan
Puerto Rico	San Juan City Hospital	San Juan
United States	Anaheim Clinical Trials, LLC	Anaheim	California
United States	Texas Diabetes & Endocrinology, P.A.	Austin	Texas
United States	Dallas Diabetes Research Center	Dallas	Texas
United States	Valley Research	Fresno	California
United States	Endocrine Ips, Pllc	Houston	Texas
United States	Juno Research	Houston	Texas
United States	Velocity Clinical Research, Huntington Park	Huntington Park	California
United States	East Coast Institute for Research, LLC	Jacksonville	Florida
United States	New Phase Research and Development	Knoxville	Tennessee
United States	Velocity Clinical Research, Huntington Park	Los Angeles	California
United States	Tandem Clinical Research,LLC	Marrero	Louisiana
United States	Southern Endocrinology Associates	Mesquite	Texas
United States	Suncoast Clinical Research, Inc.	New Port Richey	Florida
United States	Intend Research, LLC	Norman	Oklahoma
United States	Allegheny Endocrinology Associates	Pittsburgh	Pennsylvania
United States	Amici Clinical Research LLC	Raritan	New Jersey
United States	Rainier Clinical Research Center	Renton	Washington
United States	StudyMetrix Research	Saint Peters	Missouri
United States	Southern California Dermatology, Inc.	Santa Ana	California
United States	Perseverance Research Center	Scottsdale	Arizona
United States	Springfield Diabetes & Endocrine Center	Springfield	Illinois
United States	Cotton O'Neil Diabetes and Endocrinology Center	Topeka	Kansas
United States	Coastal Metabolic Research Centre	Ventura	California
United States	Diablo Clinical Research, Inc.	Walnut Creek	California
United States	Encore Medical Research - Weston	Weston	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Percent Change From Baseline in Body Weight	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.	Baseline, Week 24
Secondary	Mean Percent Change From Baseline in Body Weight	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.	Baseline, Week 48
Secondary	Percentage of Participants Who Achieve = 5% Body Weight Reduction	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.	Week 24
Secondary	Percentage of Participants Who Achieve = 5% Body Weight Reduction	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.	Week 48
Secondary	Percentage of Participants Who Achieve = 10% Body Weight Reduction	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.	Week 24
Secondary	Percentage of Participants Who Achieve = 10% Body Weight Reduction	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.	Week 48
Secondary	Percentage of Participants Who Achieve = 15% Body Weight Reduction	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.	Week 24
Secondary	Percentage of Participants Who Achieve = 15% Body Weight Reduction	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.	Week 48
Secondary	Mean Change From Baseline in Body Weight	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.	Baseline, Week 24
Secondary	Mean Change From Baseline in Body Weight	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.	Baseline, Week 48
Secondary	Mean Change From Baseline in BMI	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.	Baseline, Week 24
Secondary	Mean Change From Baseline in BMI	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.	Baseline, Week 48
Secondary	Mean Change From Baseline in Waist Circumference	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.	Baseline, Week 24
Secondary	Mean Change From Baseline in Waist Circumference	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.	Baseline, Week 48

External Links

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