Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04881760
Other study ID # 18122
Secondary ID J1I-MC-GZBF
Status Completed
Phase Phase 2
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Recruiting NCT04243317 - Feasibility of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults N/A
Recruiting NCT04101669 - EndoBarrier System Pivotal Trial(Rev E v2) N/A
Terminated NCT03772886 - Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball N/A
Completed NCT03640442 - Modified Ramped Position for Intubation of Obese Females. N/A
Completed NCT04506996 - Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2 N/A
Recruiting NCT06019832 - Analysis of Stem and Non-Stem Tibial Component N/A
Active, not recruiting NCT05891834 - Study of INV-202 in Patients With Obesity and Metabolic Syndrome Phase 2
Active, not recruiting NCT05275959 - Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI) N/A
Recruiting NCT04575194 - Study of the Cardiometabolic Effects of Obesity Pharmacotherapy Phase 4
Completed NCT04513769 - Nutritious Eating With Soul at Rare Variety Cafe N/A
Withdrawn NCT03042897 - Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer N/A
Completed NCT03644524 - Heat Therapy and Cardiometabolic Health in Obese Women N/A
Recruiting NCT05917873 - Metabolic Effects of Four-week Lactate-ketone Ester Supplementation N/A
Active, not recruiting NCT04353258 - Research Intervention to Support Healthy Eating and Exercise N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Recruiting NCT03227575 - Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control N/A
Completed NCT01870947 - Assisted Exercise in Obese Endometrial Cancer Patients N/A
Recruiting NCT05972564 - The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function Phase 1/Phase 2
Recruiting NCT06007404 - Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
Recruiting NCT05371496 - Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction Phase 2