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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05051579
Recruitment Status : Recruiting
First Posted : September 21, 2021
Last Update Posted : January 6, 2022
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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Brief Summary:
The main purpose of the study is to assess the effect of LY3502970 in participants who have obesity or are overweight

Condition or disease Intervention/treatment Phase
Obesity Overweight and Obesity Drug: LY3502970 Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 270 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : September 29, 2021
Estimated Primary Completion Date : September 29, 2022
Estimated Study Completion Date : September 29, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arms and Interventions
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Arm Intervention/treatment
Experimental: LY3502970 Dose 1
Participants will receive LY3502970 administered orally
 Drug: LY3502970
Administered orally
Experimental: LY3502970 Dose 2
Participants will receive LY3502970 administered orally
 Drug: LY3502970
Administered orally
Experimental: LY3502970 Dose 3
Participants will receive LY3502970 administered orally
 Drug: LY3502970
Administered orally
Experimental: LY3502970 Dose 4
Participants will receive LY3502970 administered orally
 Drug: LY3502970
Administered orally
Placebo Comparator: Placebo
Placebo administered orally
 Drug: Placebo
Administered orally


Outcome Measures
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Primary Outcome Measures :
  1. Percent Change From Baseline in Body Weight [ Time Frame: Baseline, Week 26 ]
    Percent Change From Baseline in Body Weight


Secondary Outcome Measures :
  1. Percent Change From Baseline in Body Weight [ Time Frame: Baseline, Week 36 ]
    Percent Change From Baseline in Body Weight

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

  3. Change From Baseline in Body Weight [ Time Frame: Baseline, Week 36 ]
    Change From Baseline in Body Weight

  4. Percentage of Participants Who Achieve ≥5% in Body Weight [ Time Frame: Week 26 ]
    Percentage of Participants Who Achieve ≥5% in Body Weight

  5. Percentage of Participants Who Achieve ≥5% in Body Weight [ Time Frame: Week 36 ]
    Percentage of Participants Who Achieve ≥5% in Body Weight

  6. Percentage of Participants Who Achieve ≥10% in Body Weight [ Time Frame: Week 26 ]
    Percentage of Participants Who Achieve ≥10% in Body Weight

  7. Percentage of Participants Who Achieve ≥10% in Body Weight [ Time Frame: Week 36 ]
    Percentage of Participants Who Achieve ≥10% in Body Weight

  8. Percent Change From Baseline in Body Mass Index (BMI) [ Time Frame: Baseline, Week 26 ]
    Percent Change From Baseline in BMI

  9. Percent Change From Baseline in BMI [ Time Frame: Baseline, Week 36 ]
    Percent Change From Baseline in BMI

  10. Change From Baseline in Waist Circumference [ Time Frame: Baseline, Week 26 ]
    Change From Baseline in Waist Circumference

  11. Change From Baseline in Waist Circumference [ Time Frame: Baseline, Week 36 ]
    Change From Baseline in Waist Circumference

  12. Pharmacokinetics (PK): Steady State Area Under the Concentration Curve (AUC) of LY3502970 [ Time Frame: Baseline to Week 36 ]
    PK: Steady State AUC of LY3502970


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05051579


Contacts
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Contact: There may be multiple sites in this clinical trial 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 ClinicalTrial.gov@lilly.com

Locations
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Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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
More Information
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Additional Information:

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT05051579    
Other Study ID Numbers: 18210
J2A-MC-GZGI ( Other Identifier: Eli Lilly and Company )
2021-002805-88 ( EudraCT Number )
First Posted: September 21, 2021    Key Record Dates
Last Update Posted: January 6, 2022
Last Verified: January 2022
Individual Participant Data (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
Statistical Analysis Plan (SAP)
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/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight