Phase 2
N=272
A Study of LY3502970 in Participants With Obesity or Overweight With Weight-related Comorbidities
Obesity · Overweight and Obesity
Bottom Line
View on ClinicalTrials.gov: NCT05051579 ↗Enrolled (actual)
272
Serious AEs
2.6%
Results posted
Sep 2023
Primary outcome: Primary: Percent Change From Baseline in Body Weight in LY3502970 and Placebo — -8.6; -11.2; -12.3; -12.6 Percent change — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- LY3502970 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Aug 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Body Weight in LY3502970 and Placebo |
-9.4; -12.5; -13.5; -14.7; -2.3 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Body Weight in LY3502970 and Placebo |
-9.4; -12.5; -13.5; -14.7; -2.3 | <0.001 sig |
| SECONDARY Change From Baseline in Body Weight in LY3502970 and Placebo |
-9.8; -13.6; -14.2; -15.4; -2.4 | <0.001 sig |
| SECONDARY Change From Baseline in Body Weight in LY3502970 and Placebo |
-9.8; -13.6; -14.2; -15.4; -2.4 | <0.001 sig |
| SECONDARY Change From Baseline in Waist Circumference in LY3502970 and Placebo |
-9.6; -11.2; -10.6; -13.6; -4.0 | <0.001 sig |
| SECONDARY Change From Baseline in Waist Circumference in LY3502970 and Placebo |
-9.6; -11.2; -10.6; -13.6; -4.0 | <0.001 sig |
| SECONDARY Change From Baseline in BMI in LY3502970 and Placebo |
-3.4; -4.7; -5.0; -5.5; -0.9 | <0.001 sig |
| SECONDARY Change From Baseline in BMI in LY3502970 and Placebo |
-3.4; -4.7; -5.0; -5.5; -0.9 | <0.001 sig |
| SECONDARY Percentage of Participants With >=5% Body Weight Loss |
72.00; 89.47; 92.05; 90.44; 24.02 | <0.001 sig |
| SECONDARY Percentage of Participants With >=10% Body Weight Loss |
46.50; 61.88; 74.75; 69.07; 8.85 | <0.001 sig |
| SECONDARY Percentage of Participants With >=5% Body Weight Loss |
72.00; 89.47; 92.05; 90.44; 24.02 | <0.001 sig |
| SECONDARY Percentage of Participants With >=10% Body Weight Loss |
46.50; 61.88; 74.75; 69.07; 8.85 | <0.001 sig |
Summary
The main purpose of the study was to assess the effect of LY3502970 in participants who have obesity or are overweight.
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
Data sourced from ClinicalTrials.gov (NCT05051579). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.