A Study of LY3502970 in Participants With Obesity or Overweight With Weight-related Comorbidities
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| ClinicalTrials.gov Identifier: NCT05051579 |
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Recruitment Status :
Completed
First Posted : September 21, 2021
Results First Posted : September 13, 2023
Last Update Posted : September 13, 2023
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Sponsor:
Eli Lilly and Company
Information provided by (Responsible Party):
Eli Lilly and Company
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Brief Summary:
The main purpose of the study was 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 22, 2022 |
| Arm | Intervention/treatment |
|---|---|
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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.
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Drug: LY3502970
Administered orally |
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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.
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Drug: LY3502970
Administered orally |
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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.
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Drug: LY3502970
Administered orally |
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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.
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Drug: LY3502970
Administered orally |
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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.
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Drug: LY3502970
Administered orally |
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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.
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Drug: LY3502970
Administered orally |
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Placebo Comparator: Placebo
Participants received placebo administered orally once daily until 36 weeks.
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Drug: Placebo
Administered orally |
Primary Outcome Measures :
- 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.
Secondary Outcome Measures :
- 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.
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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 |
Study Documents (Full-Text)
Documents provided by Eli Lilly and Company:
Documents provided by Eli Lilly and Company:
Study Protocol [PDF] September 27, 2021
Statistical Analysis Plan [PDF] October 3, 2022
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 |
| Results First Posted: | September 13, 2023 |
| Last Update Posted: | September 13, 2023 |
| Last Verified: | August 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 |