A Study of LY3437943 in Participants Who Have Obesity or Are Overweight
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04881760 |
Recruitment Status :
Active, not recruiting
First Posted : May 11, 2021
Last Update Posted : May 11, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Obesity Overweight | Drug: LY3437943 Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 494 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Phase 2 Study of Once-Weekly LY3437943 Compared With Placebo in Participants Who Have Obesity or Are Overweight With Weight-Related Comorbidities |
Actual Study Start Date : | May 20, 2021 |
Estimated Primary Completion Date : | May 16, 2022 |
Estimated Study Completion Date : | November 28, 2022 |
Arm | Intervention/treatment |
---|---|
Experimental: LY3437943 Dose 1
LY3437943 administered subcutaneously (SC)
|
Drug: LY3437943
Administered SC |
Experimental: LY3437943 Dose 2
LY3437943 administered SC
|
Drug: LY3437943
Administered SC |
Experimental: LY3437943 Dose 3
LY3437943 administered SC
|
Drug: LY3437943
Administered SC |
Experimental: LY3437943 Dose 4
LY3437943 administered SC
|
Drug: LY3437943
Administered SC |
Placebo Comparator: Placebo
Placebo administered SC
|
Drug: Placebo
Administered SC |
- Mean Percent Change in Body Weight [ Time Frame: Randomization, Week 24 ]
- Mean Percent Change in Body Weight [ Time Frame: Randomization, Week 48 ]
- Percentage of Participants Who Achieve ≥5% Body Weight Reduction [ Time Frame: Week 24 ]
- Percentage of Participants Who Achieve ≥5% Body Weight Reduction [ Time Frame: Week 48 ]
- Percentage of Participants Who Achieve ≥10% Body Weight Reduction [ Time Frame: Week 24 ]
- Percentage of Participants Who Achieve ≥10% Body Weight Reduction [ Time Frame: Week 48 ]
- Percentage of Participants Who Achieve ≥15% Body Weight Reduction [ Time Frame: Week 24 ]
- Percentage of Participants Who Achieve ≥15% Body Weight Reduction [ Time Frame: Week 48 ]
- Mean Change from Randomization in Body Weight [ Time Frame: Randomization, Week 24 ]
- Mean Change from Randomization in Body Weight [ Time Frame: Randomization, Week 48 ]
- Mean Change from Randomization in Body Mass Index (BMI) [ Time Frame: Randomization, Week 24 ]
- Mean Change from Randomization in BMI [ Time Frame: Randomization, Week 48 ]
- Mean Change from Randomization in Waist Circumference [ Time Frame: Randomization, Week 24 ]
- Mean Change from Randomization in Waist Circumference [ Time Frame: Randomization, Week 48 ]

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04881760

Study Director: | Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company |
Responsible Party: | Eli Lilly and Company |
ClinicalTrials.gov Identifier: | NCT04881760 |
Other Study ID Numbers: |
18122 J1I-MC-GZBF ( Other Identifier: Eli Lilly and Company ) |
First Posted: | May 11, 2021 Key Record Dates |
Last Update Posted: | May 11, 2022 |
Last Verified: | May 1, 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement. |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Clinical Study Report (CSR) |
Time Frame: | Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting. |
Access Criteria: | A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement. |
URL: | https://vivli.org/ |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Nutritional or Metabolism Disorder Weight Loss Overnutrition |
Incretins Hormones Physiological Effects of Drugs |
Obesity Overweight Overnutrition Nutrition Disorders Body Weight |