Clinical trial

A Phase 2 Study of Once-Daily LY3502970 Compared With Placebo in Participants Who Have Obesity or Are Overweight With Weight-Related Comorbidities

Name
18210
Description
The main purpose of the study was to assess the effect of LY3502970 in participants who have obesity or are overweight.
Trial arms
Trial start
2021-09-29
Estimated PCD
2022-08-25
Trial end
2022-11-22
Status
Completed
Phase
Early phase I
Treatment
LY3502970
Administered orally
Arms:
12 milligram (mg) LY3502970, 24 mg LY3502970, 36 mg-1 LY3502970, 36 mg-2 LY3502970, 45 mg-1 LY3502970, 45 mg-2 LY3502970
Placebo
Administered orally
Arms:
Placebo
Size
272
Primary endpoint
Percent Change From Baseline in Body Weight in LY3502970 and Placebo
Baseline, Week 26
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 272, 'type': 'ACTUAL'}}
Updated at
2023-09-13

1 organization

2 products

1 indication

Product
Placebo
Indication
Obesity
Product
LY3502970