A Study of LY3502970 in Participants With Obesity or Overweight With Weight-related Comorbidities
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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. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT05051579 |
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Recruitment Status :
Completed
First Posted : September 21, 2021
Last Update Posted : January 10, 2023
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Sponsor:
Eli Lilly and Company
Information provided by (Responsible Party):
Eli Lilly and Company
- Study Details
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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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 272 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 |
| Actual Primary Completion Date : | August 25, 2022 |
| Actual Study Completion Date : | November 21, 2022 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: LY3502970 Dose 1
Participants will receive LY3502970 administered orally
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Drug: LY3502970
Administered orally |
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Experimental: LY3502970 Dose 2
Participants will receive LY3502970 administered orally
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Drug: LY3502970
Administered orally |
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Experimental: LY3502970 Dose 3
Participants will receive LY3502970 administered orally
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Drug: LY3502970
Administered orally |
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Experimental: LY3502970 Dose 4
Participants will receive LY3502970 administered orally
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Drug: LY3502970
Administered orally |
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Placebo Comparator: Placebo
Placebo administered orally
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Drug: Placebo
Administered orally |
Primary Outcome Measures :
- Percent Change From Baseline in Body Weight [ Time Frame: Baseline, Week 26 ]Percent Change From Baseline in Body Weight
Secondary Outcome Measures :
- 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
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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
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
Locations
Show 35 study locations
Sponsors and Collaborators
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 |
Additional Information:
| 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 10, 2023 |
| Last Verified: | January 2023 |
| 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/ |
| 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 |