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Phase 2 N=272 Randomized Double-blind Treatment

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

Obesity · Overweight and Obesity

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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