A Study of LY3502970 in Participants With Obesity or Overweight With Weight-related Comorbidities

A Phase 2 Study of Once-Daily LY3502970 Compared With Placebo in Participants Who Have Obesity or Are Overweight With Weight-Related Comorbidities

The main purpose of the study was to assess the effect of LY3502970 in participants who have obesity or are overweight.

Study Overview

• Status: Completed
• Conditions: Obesity; Overweight and Obesity
• Intervention / Treatment: Drug: Placebo; Drug: LY3502970

• Study Type: Interventional
• Enrollment (Actual): 272
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada, G2J 0C4
    • ALPHA Recherche Clinique
  • Quebec, Canada, G3K 2P8
    • ALPHA Recherche Clinique
  • Alberta
    • Calgary, Alberta, Canada, T2V 4J2
      • C-health Research
  • Ontario
    • Hamilton, Ontario, Canada, L8L 5G8
      • Wharton Medical Clinic
    • Sarnia, Ontario, Canada, N7T 4X3
      • Bluewater Clinical Research Group Inc.
  • Quebec
    • Saint Marc des Carrières, Quebec, Canada, G0A 4B0
      • Centre Médical et Professionnel de l'Ouest de Portneuf
• Hungary
  • Budapest, Hungary, 1033
    • Clinexpert Kft.
  • Budapest, Hungary, 1032
    • Szent Margit Rendelőintézet Nonprofit Kft
  • Budapest, Hungary, 1213
    • TRANTOR'99 Bt. Anyagcsere Centrum
  • Budapest, Hungary, H1171
    • Strazsahegy Medicina Bt.
  • Debrecen, Hungary, 4032
    • Debreceni Egyetem Klinikai Kozpont
  • Bács-Kiskun
    • Kalocsa, Bács-Kiskun, Hungary, 6300
      • Studium Egeszseghaz Kft
  • Heves
    • Gyongyos, Heves, Hungary, 3200
      • Bugat Pal Korhaz
  • Veszprém
    • Balatonfüred, Veszprém, Hungary, 8230
      • DRC Gyógyszervizsgáló Központ
  • Zala
    • Nagykanizsa, Zala, Hungary, 8800
      • Kanizsai Dorottya Korhaz
• Puerto Rico
  • Ponce, Puerto Rico, 00717
    • Puerto Rico Medical Research
  • Ponce, Puerto Rico, 00717
    • Research and Cardiovascular Corp.
• United States
  • California
    • Anaheim, California, United States, 92801
      • Anaheim Clinical Trials, LLC
    • Concord, California, United States, 94520
      • John Muir Physician Network Research Center
    • Greenbrae, California, United States, 94904
      • NorCal Medical Research, Inc
    • Northridge, California, United States, 91325
      • Valley Clinical Trials, Inc.
    • San Ramon, California, United States, 94583
      • Norcal Endocrinology & Internal Medicine
  • Idaho
    • Blackfoot, Idaho, United States, 83221
      • Elite Clinical Trials
    • Idaho Falls, Idaho, United States, 83404
      • Rocky Mountain Clinical Research
  • Missouri
    • Saint Peters, Missouri, United States, 63303
      • StudyMetrix Research
  • New Jersey
    • Trenton, New Jersey, United States, 08611
      • Premier Research
  • North Dakota
    • Fargo, North Dakota, United States, 58104
      • Lillestol Research
  • Oklahoma
    • Norman, Oklahoma, United States, 73069
      • Intend Research, LLC
  • Pennsylvania
    • Camp Hill, Pennsylvania, United States, 17011
      • Capital Area Research, LLC
    • Pittsburgh, Pennsylvania, United States, 15243
      • Preferred Primary Care Physicians, Preferred Clinical Research-St. Clair
  • Texas
    • Dallas, Texas, United States, 75230
      • Dallas Diabetes Research Center
    • Fort Worth, Texas, United States, 76132
      • Diabetes and Thyroid Center of Fort Worth
    • Round Rock, Texas, United States, 78681
      • Texas Diabetes & Endocrinology, P.A.
  • Virginia
    • Richmond, Virginia, United States, 23294
      • National Clinical Research, Inc
  • Wisconsin
    • Green Bay, Wisconsin, United States, 54303
      • St. Vincent Hospital d/b/a Prevea Health

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Have a body mass index (BMI) of ≥30-kilogram square meter (kg/m²)
• Have a BMI ≥27 kg/m² and <30 kg/m² with at least 1 of the following weight-related comorbidities eg; [Have hypertension, or dyslipidemia, cardiovascular disease]
• Have had a stable body weight for the 3 months prior to randomization (not more than 5% body weight gain and/or loss)

Exclusion Criteria:

• Have any prior diagnosis of diabetes
• Have a prior or planned surgical treatment for obesity
• Have obesity induced by other endocrinological disorders or diagnosed monogenetic or syndromic forms of obesity
• Have renal impairment measured as estimated glomerular filtration rate (eGFR) <30 milliliter (mL)/minute (min)/1.73 m²
• Have a history of acute chronic pancreatitis
• Have a history of significant active or unstable Major Depressive Disorder (MDD) or other severe psychiatric disorder (for example, schizophrenia, bipolar disorder, or other serious mood or anxiety disorder) within the last 2 years Note: Participants with MDD or generalized anxiety disorder whose disease state is considered stable for the past 2 years and expected to remain stable throughout the course of the study, may be considered for inclusion if they are not on excluded medications.

Within 3 months prior to screening:

• Have poorly controlled hypertension
• Have history of acute myocardial infarction
• Have history of cerebrovascular accident (stroke)
• Had hospitalization due to congestive heart failure (CHF)
• Have cancer
• Have human immunodeficiency virus (HIV) and/or positive HIV antibodies historically or at screening
• Have hepatitis B and/or positive hepatitis B surface antigen

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: 12 milligram (mg) LY3502970; Participants received maintenance dose 12 mg with dose escalation starting from 3 mg,6 mg and then 12 mg LY3502970 administered orally once daily until 36 weeks.	Drug: LY3502970; Administered orally
Experimental: 24 mg LY3502970; Participants received maintenance dose 24 mg with dose escalation starting from 3 mg, 6 mg, 8 mg,12 mg and then 24 mg LY3502970 administered orally once daily until 36 weeks.	Drug: LY3502970; Administered orally
Experimental: 36 mg-1 LY3502970; Participants received maintenance dose 36 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 8 mg, 12 mg, 24 mg and then 36 mg LY3502970 administered orally once daily until 36 weeks.	Drug: LY3502970; Administered orally
Experimental: 36 mg-2 LY3502970; Participants received maintenance dose 36 mg with dose escalation starting from 3 mg, 6 mg,12 mg, 24 mg and then 36 mg LY3502970 administered orally once daily until 36 weeks.	Drug: LY3502970; Administered orally
Experimental: 45 mg-1 LY3502970; Participants received maintenance dose 45 mg with dose escalation starting from 3 mg, 6 mg, 8 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 administered orally once daily until 36 weeks.	Drug: LY3502970; Administered orally
Experimental: 45 mg-2 LY3502970; Participants received maintenance dose 45 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 administered orally once daily until 36 weeks.	Drug: LY3502970; Administered orally
Placebo Comparator: Placebo; Participants received placebo administered orally once daily until 36 weeks.	Drug: Placebo; Administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change From Baseline in Body Weight in LY3502970 and Placebo	Least Squares (LS) mean was determined by mixed model repeated measures (MMRM) model with Baseline + Baseline BMI Group + Sex + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Percent Change from Baseline) = Unstructured.	Baseline, Week 26

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change From Baseline in Body Weight in LY3502970 and Placebo	LS mean was determined by MMRM model with Baseline + Baseline BMI Group + Sex + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Percent Change from Baseline) = Unstructured.	Baseline, Week 36
Change From Baseline in Body Weight in LY3502970 and Placebo	LS mean was determined by MMRM model with Baseline + Baseline BMI Group + Sex + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Percent Change from Baseline) = Unstructured.	Baseline, Week 26
Change From Baseline in Body Weight in LY3502970 and Placebo	LS mean was determined by MMRM model with Baseline + Baseline BMI Group + Sex + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Percent Change from Baseline) = Unstructured.	Baseline, Week 36
Change From Baseline in Waist Circumference in LY3502970 and Placebo	LS mean was determined by MMRM model with Baseline + Baseline BMI Group + Sex + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Percent Change from Baseline) = Unstructured.	Baseline, Week 26
Change From Baseline in Waist Circumference in LY3502970 and Placebo	LS mean was determined by MMRM model with Baseline + Baseline BMI Group + Sex + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Percent Change from Baseline) = Unstructured.	Baseline, Week 36
Change From Baseline in BMI in LY3502970 and Placebo	LS mean was determined by MMRM model with Baseline + Baseline BMI Group + Sex + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Percent Change from Baseline) = Unstructured.	Baseline, Week 26
Change From Baseline in BMI in LY3502970 and Placebo	LS mean was determined by MMRM model with Baseline + Baseline BMI Group + Sex + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Percent Change from Baseline) = Unstructured.	Baseline, Week 36
Percentage of Participants With >=5% Body Weight Loss	Percentage of participants with >=5% body weight loss was reported.	Week 26
Percentage of Participants With >=10% Body Weight Loss	Percentage of participants with >=10% body weight loss was reported.	Week 26
Percentage of Participants With >=5% Body Weight Loss	Percentage of participants with >=5% body weight loss was reported.	Week 36
Percentage of Participants With >=10% Body Weight Loss	Percentage of participants with >=10% body weight loss was reported.	Week 36

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-5615-4559 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 LY3502970 in Participants With Obesity or Overweight With Weight-related Comorbidities

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2021
• Primary Completion (Actual): August 25, 2022
• Study Completion (Actual): November 22, 2022

Study Registration Dates

• First Submitted: September 17, 2021
• First Submitted That Met QC Criteria: September 17, 2021
• First Posted (Actual): September 21, 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

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Obesity; Overweight
• Other Study ID Numbers: 18210; J2A-MC-GZGI (Other Identifier: Eli Lilly and Company); 2021-002805-88 (EudraCT Number)

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
• product manufactured in and exported from the U.S.: No