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

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Overweight
• Intervention / Treatment: Drug: Placebo; Drug: LY3437943

• Study Type: Interventional
• Enrollment (Actual): 338
• Phase: Phase 2

Contacts and Locations

Study Locations

• Puerto Rico
  • Guaynabo, Puerto Rico, 00970
    • Private Practice - Dr. Paola Mansilla-Letelier
  • San Juan, Puerto Rico, 00917
    • GCM Medical Group, PSC - Hato Rey Site
  • San Juan, Puerto Rico, 00935
    • San Juan City Hospital
• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85254
      • Perseverance Research Center
  • California
    • Anaheim, California, United States, 92801
      • Anaheim Clinical Trials, LLC
    • Fresno, California, United States, 93720
      • Valley Research
    • Huntington Park, California, United States, 90255
      • Velocity Clinical Research, Huntington Park
    • Los Angeles, California, United States, 90057
      • Velocity Clinical Research, Huntington Park
    • Santa Ana, California, United States, 92701
      • Southern California Dermatology, Inc.
    • Ventura, California, United States, 93003
      • Coastal Metabolic Research Centre
    • Walnut Creek, California, United States, 94598
      • Diablo Clinical Research, Inc.
  • Florida
    • Jacksonville, Florida, United States, 32216
      • East Coast Institute for Research, LLC
    • New Port Richey, Florida, United States, 34652
      • Suncoast Clinical Research, Inc.
    • Weston, Florida, United States, 33331
      • Encore Medical Research - Weston
  • Illinois
    • Springfield, Illinois, United States, 62711
      • Springfield Diabetes & Endocrine Center
  • Kansas
    • Topeka, Kansas, United States, 66606
      • Cotton O'Neil Diabetes and Endocrinology Center
  • Louisiana
    • Marrero, Louisiana, United States, 70072
      • Tandem Clinical Research,LLC
  • Missouri
    • Saint Peters, Missouri, United States, 63303
      • StudyMetrix Research
  • New Jersey
    • Raritan, New Jersey, United States, 08869
      • Amici Clinical Research LLC
  • Oklahoma
    • Norman, Oklahoma, United States, 73069
      • Intend Research, LLC
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny Endocrinology Associates
  • Tennessee
    • Knoxville, Tennessee, United States, 37909
      • New Phase Research and Development
  • Texas
    • Austin, Texas, United States, 78731
      • Texas Diabetes & Endocrinology, P.A.
    • Dallas, Texas, United States, 75230
      • Dallas Diabetes Research Center
    • Houston, Texas, United States, 77054
      • Juno Research
    • Houston, Texas, United States, 77079
      • Endocrine Ips, Pllc
    • Mesquite, Texas, United States, 75149
      • Southern Endocrinology Associates
  • Washington
    • Renton, Washington, United States, 98057
      • Rainier Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 4 mg LY3437943 (2 mg); Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 administered as SC injection QW.	Drug: LY3437943; Administered SC
Experimental: 8 mg LY3437943 (2 mg); Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 and then 8 mg LY3437943 administered as SC injection QW.	Drug: LY3437943; Administered SC
Placebo Comparator: Placebo; Participants received placebo matched to LY3437943 administered as subcutaneous (SC) injection once-weekly (QW).	Drug: Placebo; Administered SC
Experimental: 1 milligram (mg) LY3437943; Participants received 1 mg LY3437943 administered as SC injection QW.	Drug: LY3437943; Administered SC
Experimental: 4 mg LY3437943; Participants received 4 mg LY3437943 administered as SC injection QW.	Drug: LY3437943; Administered SC
Experimental: 8 mg LY3437943 (4 mg); Participants received 4 mg LY3437943 starting dose followed by 8 mg LY3437943 administered as SC injection QW.	Drug: LY3437943; Administered SC
Experimental: 12 mg LY3437943 (2 mg); 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.	Drug: LY3437943; Administered SC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2021
• Primary Completion (Actual): May 16, 2022
• Study Completion (Actual): November 22, 2022

Study Registration Dates

• First Submitted: May 10, 2021
• First Submitted That Met QC Criteria: May 10, 2021
• First Posted (Actual): May 11, 2021

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: August 23, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Weight Loss; Physiological Effects of Drugs; Incretins; Overnutrition; Hormones; Nutritional or Metabolism Disorder
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Obesity; Overweight
• Other Study ID Numbers: 18122; J1I-MC-GZBF (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
• IPD Sharing Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
• IPD Sharing Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No