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Completed

NCT Number: NCT05051579

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

The main purpose of the study was to assess the effect of LY3502970 in participants who have obesity or are overweight.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Overweight and Obesity Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

C-health Research, Calgary, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LY3502970

Drug

Administered orally

Placebo

Drug

Administered orally

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. Percentage of Participants With >=5% Body Weight Loss

    Time frame: Week 26

    Percentage of participants with >=5% body weight loss was reported.

  9. Percentage of Participants With >=10% Body Weight Loss

    Time frame: Week 26

    Percentage of participants with >=10% body weight loss was reported.

  10. Percentage of Participants With >=5% Body Weight Loss

    Time frame: Week 36

    Percentage of participants with >=5% body weight loss was reported.

  11. Percentage of Participants With >=10% Body Weight Loss

    Time frame: Week 36

    Percentage of participants with >=10% body weight loss was reported.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 21, 2021
Registry last updated
Sep 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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