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

• ClinicalTrials.gov Identifier: NCT05051579
• Recruitment Status: Completed
• First Posted: September 21, 2021
• Results First Posted: September 13, 2023
• Last Update Posted: September 13, 2023
• Sponsor: Eli Lilly and Company
• Information provided by (Responsible Party): Eli Lilly and Company

Tracking Information

• First Submitted Date: September 17, 2021
• First Posted Date: September 21, 2021
• Results First Submitted Date: August 23, 2023
• Results First Posted Date: September 13, 2023
• Last Update Posted Date: September 13, 2023
• Actual Study Start Date: September 29, 2021
• Actual Primary Completion Date: August 25, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 23, 2023)

Percent Change From Baseline in Body Weight in LY3502970 and Placebo [ Time Frame: Baseline, Week 26 ]

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.

Original Primary Outcome Measures (submitted: September 17, 2021)

Percent Change From Baseline in Body Weight [ Time Frame: Baseline, Week 26 ]

Percent Change From Baseline in Body Weight

Current Secondary Outcome Measures (submitted: August 23, 2023)

• Percent Change From Baseline in Body Weight in LY3502970 and Placebo [ Time Frame: Baseline, Week 36 ]
  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.
• Change From Baseline in Body Weight in LY3502970 and Placebo [ Time Frame: Baseline, Week 26 ]
  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.
• Change From Baseline in Body Weight in LY3502970 and Placebo [ Time Frame: Baseline, Week 36 ]
  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.
• Change From Baseline in Waist Circumference in LY3502970 and Placebo [ Time Frame: Baseline, Week 26 ]
  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.
• Change From Baseline in Waist Circumference in LY3502970 and Placebo [ Time Frame: Baseline, Week 36 ]
  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.
• Change From Baseline in BMI in LY3502970 and Placebo [ Time Frame: Baseline, Week 26 ]
  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.
• Change From Baseline in BMI in LY3502970 and Placebo [ Time Frame: Baseline, Week 36 ]
  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.
• Percentage of Participants With >=5% Body Weight Loss [ Time Frame: Week 26 ]
  Percentage of participants with >=5% body weight loss was reported.
• Percentage of Participants With >=10% Body Weight Loss [ Time Frame: Week 26 ]
  Percentage of participants with >=10% body weight loss was reported.
• Percentage of Participants With >=5% Body Weight Loss [ Time Frame: Week 36 ]
  Percentage of participants with >=5% body weight loss was reported.
• Percentage of Participants With >=10% Body Weight Loss [ Time Frame: Week 36 ]
  Percentage of participants with >=10% body weight loss was reported.

Original Secondary Outcome Measures (submitted: September 17, 2021)

• Percent Change From Baseline in Body Weight [ Time Frame: Baseline, Week 36 ]
  Percent Change From Baseline in Body Weight
• Change From Baseline in Body Weight [ Time Frame: Baseline, Week 26 ]
  Change From Baseline in Body Weight
• Change From Baseline in Body Weight [ Time Frame: Baseline, Week 36 ]
  Change From Baseline in Body Weight
• Percentage of Participants Who Achieve ≥5% in Body Weight [ Time Frame: Week 26 ]
  Percentage of Participants Who Achieve ≥5% in Body Weight
• Percentage of Participants Who Achieve ≥5% in Body Weight [ Time Frame: Week 36 ]
  Percentage of Participants Who Achieve ≥5% in Body Weight
• Percentage of Participants Who Achieve ≥10% in Body Weight [ Time Frame: Week 26 ]
  Percentage of Participants Who Achieve ≥10% in Body Weight
• Percentage of Participants Who Achieve ≥10% in Body Weight [ Time Frame: Week 36 ]
  Percentage of Participants Who Achieve ≥10% in Body Weight
• Percent Change From Baseline in Body Mass Index (BMI) [ Time Frame: Baseline, Week 26 ]
  Percent Change From Baseline in BMI
• Percent Change From Baseline in BMI [ Time Frame: Baseline, Week 36 ]
  Percent Change From Baseline in BMI
• Change From Baseline in Waist Circumference [ Time Frame: Baseline, Week 26 ]
  Change From Baseline in Waist Circumference
• Change From Baseline in Waist Circumference [ Time Frame: Baseline, Week 36 ]
  Change From Baseline in Waist Circumference
• Pharmacokinetics (PK): Steady State Area Under the Concentration Curve (AUC) of LY3502970 [ Time Frame: Baseline to Week 36 ]
  PK: Steady State AUC of LY3502970

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study of LY3502970 in Participants With Obesity or Overweight With Weight-related Comorbidities
• Official Title: A Phase 2 Study of Once-Daily LY3502970 Compared With Placebo in Participants Who Have Obesity or Are Overweight With Weight-Related Comorbidities
• Brief Summary: The main purpose of the study was to assess the effect of LY3502970 in participants who have obesity or are overweight.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment

Condition

• Obesity
• Overweight and Obesity

Intervention

• Drug: LY3502970
  Administered orally
• Drug: Placebo
  Administered orally

Study Arms

• 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.
  Intervention: Drug: LY3502970
• 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.
  Intervention: Drug: LY3502970
• 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.
  Intervention: Drug: LY3502970
• 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.
  Intervention: Drug: LY3502970
• 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.
  Intervention: Drug: LY3502970
• 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.
  Intervention: Drug: LY3502970
• Placebo Comparator: Placebo
  Participants received placebo administered orally once daily until 36 weeks.
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 6, 2023): 272
• Original Estimated Enrollment (submitted: September 17, 2021): 270
• Actual Study Completion Date: November 22, 2022
• Actual Primary Completion Date: August 25, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada, Hungary, Puerto Rico, United States

Administrative Information

• NCT Number: NCT05051579
• Other Study ID Numbers: 18210; J2A-MC-GZGI ( Other Identifier: Eli Lilly and Company ); 2021-002805-88 ( EudraCT Number )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• 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.
• Supporting Materials: Study Protocol
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: Clinical Study Report (CSR)
• 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.
• Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
• URL: https://vivli.org/

• Current Responsible Party: Eli Lilly and Company
• Original Responsible Party: Same as current
• Current Study Sponsor: Eli Lilly and Company
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

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

• PRS Account: Eli Lilly and Company
• Verification Date: August 2023