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Completed

NCT Number: NCT04881760

A Study of LY3437943 in Participants Who Have Obesity or Are Overweight

This is a study of LY3437943 in participants who have obesity or are overweight. The main purpose is to learn more about how LY3437943 affects body weight loss. The study will last about 18 months and may include up to 18 visits.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Private Practice - Dr. Paola Mansilla-Letelier, Guaynabo, Puerto Rico

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Participants must have a Body Mass Index (BMI) ) ≥30 and ≤50 kilograms per square meter (kg/m²), or ≥27 kg/m² and <30 kg/m², with at least one of the following comorbidities: hypertension, dyslipidemia, cardiovascular disease
  • Participants must be willing to learn how to self-inject study drug or receive an injection from a trained individual if visually impaired or with physical limitations, and follow study procedures for the duration of the study, including, but not limited to, follow lifestyle advice (for example, dietary changes and physical activity plan), maintain a study drug administration log, and complete required questionnaires

Exclusion criteria

  • Participants must not have type 1 or type 2 diabetes mellitus
  • Participants must not have had an increase or decrease in body weight > more than 5 kg (11 pounds) within the past 3 months
  • Participants must not have had surgery for obesity or plan to have such surgery during the study
  • Participants must not be using medications that promote weight loss or cause weight gain
  • Participants must not drink excessive amounts of alcohol (more than 14 units a week for women or more than 21 units a week for men)
  • Participants must not have used marijuana within the last 3 months.
  • Participants must not have heart attack, stroke, or hospitalization for congestive heart failure in the past 3 months
  • Participants must not have active cancer within the last 5 years
  • Participants must not have uncontrolled high blood pressure
  • Participants must not have liver disease other than non-alcoholic fatty liver disease
  • Participants must not have renal impairment with estimated glomerular filtration rate (eGFR) <45 mL/min/1.73 m2
  • Participants must not have a history of acute or chronic pancreatitis symptomatic gallbladder disease or documented human immunodeficiency virus infection
  • Participants must not have a major problem with depression or other mental illness within the last 2 years
  • Participants must not have family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma (family is defined as a first degree relative)
  • Female participants must not be pregnant, breast-feeding, or intend to become pregnant or of childbearing potential and not using adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice)

Treatment and study plan

LY3437943

Drug

Administered SC

Placebo

Drug

Administered SC

Primary outcomes

  1. Mean Percent Change From Baseline in Body Weight

    Time frame: Baseline, Week 24

    Least squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) for post-baseline measures: Variable = Treatment*Time + Baseline BMI (< 36kg/m2 vs. >=36 kg/m2)*Time + Sex (Female vs. Male)*Time + Baseline*Time.

Secondary outcomes

  1. Mean Percent Change From Baseline in Body Weight

    Time frame: Baseline, Week 48

    LS means were calculated using a MMRM model for post-baseline measures: Variable = Treatment*Time + Baseline BMI (< 36kg/m2 vs. >=36 kg/m2)*Time + Sex (Female vs. Male)*Time + Baseline*Time.

  2. Percentage of Participants Who Achieve ≥ 5% Body Weight Reduction

    Time frame: Week 24

    Percentage of participants who achieve ≥ 5% body weight reduction in LY3437943 relative to placebo. Estimated percentage was determined by logistic regression model with an intercept term, treatment group, baseline BMI stratum [<36 kilograms per square meter (kg/m2), ≥36 kg/m2] and sex [female, male] as fixed effects, and baseline body weight as a covariate.

  3. Percentage of Participants Who Achieve ≥ 5% Body Weight Reduction

    Time frame: Week 48

    Percentage of participants who achieve ≥ 5% body weight reduction in LY3437943 relative to placebo. Estimated percentage was determined by logistic regression model with an intercept term, treatment group, baseline BMI stratum [<36 kg/m2, ≥36 kg/m2] and sex [female, male] as fixed effects, and baseline body weight as a covariate.

  4. Percentage of Participants Who Achieve ≥ 10% Body Weight Reduction

    Time frame: Week 24

    Percentage of participants who achieve ≥ 10% body weight reduction in LY3437943 relative to placebo. Estimated percentage was determined by logistic regression model with an intercept term, treatment group, baseline BMI stratum [<36 kg/m2, ≥36 kg/m2] and sex [female, male] as fixed effects, and baseline body weight as a covariate.

  5. Percentage of Participants Who Achieve ≥ 10% Body Weight Reduction

    Time frame: Week 48

    Percentage of participants who achieve ≥ 10% body weight reduction in LY3437943 relative to placebo. Estimated percentage was determined by logistic regression model with an intercept term, treatment group, baseline BMI stratum [<36 kg/m2, ≥36 kg/m2] and sex [female, male] as fixed effects, and baseline body weight as a covariate.

  6. Percentage of Participants Who Achieve ≥ 15% Body Weight Reduction

    Time frame: Week 24

    Percentage of participants who achieve ≥ 15% body weight reduction in LY3437943 relative to placebo. Estimated percentage was determined by logistic regression model with an intercept term, treatment group, baseline BMI stratum [<36 kg/m2, ≥36 kg/m2] and sex [female, male] as fixed effects, and baseline body weight as a covariate.

  7. Percentage of Participants Who Achieve ≥ 15% Body Weight Reduction

    Time frame: Week 48

    Percentage of participants who achieve ≥ 15% body weight reduction in LY3437943 relative to placebo. Estimated percentage was determined by logistic regression model with an intercept term, treatment group, baseline BMI stratum [<36 kg/m2, ≥36 kg/m2] and sex [female, male] as fixed effects, and baseline body weight as a covariate.

  8. Mean Change From Baseline in Body Weight

    Time frame: Baseline, Week 24

    LS means were calculated using a MMRM model for post-baseline measures: Variable = Treatment*Time + Baseline BMI (< 36kg/m2 vs. >=36 kg/m2)*Time + Sex (Female vs. Male)*Time + Baseline*Time.

  9. Mean Change From Baseline in Body Weight

    Time frame: Baseline, Week 48

    LS means were calculated using a MMRM model for post-baseline measures: Variable = Treatment*Time + Baseline BMI (< 36kg/m2 vs. >=36 kg/m2)*Time + Sex (Female vs. Male)*Time + Baseline*Time.

  10. Mean Change From Baseline in BMI

    Time frame: Baseline, Week 24

    LS means were calculated using a MMRM model for post-baseline measures: Variable = Treatment*Time + Baseline BMI (< 36kg/m2 vs. >=36 kg/m2)*Time + Sex (Female vs. Male)*Time + Baseline*Time.

  11. Mean Change From Baseline in BMI

    Time frame: Baseline, Week 48

    LS means were calculated using a MMRM model for post-baseline measures: Variable = Treatment*Time + Baseline BMI (< 36kg/m2 vs. >=36 kg/m2)*Time + Sex (Female vs. Male)*Time + Baseline*Time.

  12. Mean Change From Baseline in Waist Circumference

    Time frame: Baseline, Week 24

    LS means were calculated using a MMRM model for post-baseline measures: Variable = Treatment*Time + Baseline BMI (< 36kg/m2 vs. >=36 kg/m2)*Time + Sex (Female vs. Male)*Time + Baseline*Time.

  13. Mean Change From Baseline in Waist Circumference

    Time frame: Baseline, Week 48

    LS means were calculated using a MMRM model for post-baseline measures: Variable = Treatment*Time + Baseline BMI (< 36kg/m2 vs. >=36 kg/m2)*Time + Sex (Female vs. Male)*Time + Baseline*Time.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Phase 2 Study of Once-Weekly LY3437943 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
May 11, 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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