A Study of LY3437943 in Participants Who Have Obesity or Are Overweight
- Registration Number
- NCT04881760
- Lead Sponsor
- Eli Lilly and Company
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 338
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 milligram (mg) LY3437943 LY3437943 Participants received 1 mg LY3437943 administered as SC injection QW. 4 mg LY3437943 (2 mg) LY3437943 Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 administered as SC injection QW. 4 mg LY3437943 LY3437943 Participants received 4 mg LY3437943 administered as SC injection QW. Placebo Placebo Participants received placebo matched to LY3437943 administered as subcutaneous (SC) injection once-weekly (QW). 8 mg LY3437943 (2 mg) LY3437943 Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 and then 8 mg LY3437943 administered as SC injection QW. 8 mg LY3437943 (4 mg) LY3437943 Participants received 4 mg LY3437943 starting dose followed by 8 mg LY3437943 administered as SC injection QW. 12 mg LY3437943 (2 mg) LY3437943 Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943, 8 mg LY3437943 and then 12 mg LY3437943 administered as SC injection QW.
- Primary Outcome Measures
Name Time Method Mean Percent Change From Baseline in Body Weight 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 Outcome Measures
Name Time Method Mean Percent Change From Baseline in Body Weight 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 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 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 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 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 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 Waist Circumference 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.
Trial Locations
- Locations (27)
Allegheny Endocrinology Associates
🇺🇸Pittsburgh, Pennsylvania, United States
Juno Research
🇺🇸Houston, Texas, United States
Perseverance Research Center
🇺🇸Scottsdale, Arizona, United States
StudyMetrix Research
🇺🇸Saint Peters, Missouri, United States
Springfield Diabetes & Endocrine Center
🇺🇸Springfield, Illinois, United States
Cotton O'Neil Diabetes and Endocrinology Center
🇺🇸Topeka, Kansas, United States
Valley Research
🇺🇸Fresno, California, United States
Velocity Clinical Research, Huntington Park
🇺🇸Los Angeles, California, United States
Coastal Metabolic Research Centre
🇺🇸Ventura, California, United States
New Phase Research and Development
🇺🇸Knoxville, Tennessee, United States
Endocrine Ips, Pllc
🇺🇸Houston, Texas, United States
Southern Endocrinology Associates
🇺🇸Mesquite, Texas, United States
Suncoast Clinical Research, Inc.
🇺🇸New Port Richey, Florida, United States
Anaheim Clinical Trials, LLC
🇺🇸Anaheim, California, United States
Diablo Clinical Research, Inc.
🇺🇸Walnut Creek, California, United States
Encore Medical Research - Weston
🇺🇸Weston, Florida, United States
Southern California Dermatology, Inc.
🇺🇸Santa Ana, California, United States
Amici Clinical Research LLC
🇺🇸Raritan, New Jersey, United States
Intend Research, LLC
🇺🇸Norman, Oklahoma, United States
Tandem Clinical Research,LLC
🇺🇸Marrero, Louisiana, United States
Rainier Clinical Research Center
🇺🇸Renton, Washington, United States
East Coast Institute for Research, LLC
🇺🇸Jacksonville, Florida, United States
Dallas Diabetes Research Center
🇺🇸Dallas, Texas, United States
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, Puerto Rico
Texas Diabetes & Endocrinology, P.A.
🇺🇸Austin, Texas, United States