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

Lilly

Status and phase: Completed; Phase 2

Conditions: Overweight; Obesity

Treatments: Drug: LY3437943; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04881760

J1I-MC-GZBF (Other Identifier)

18122

Details and patient eligibility

About

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.

Enrollment: 338 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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338 participants in 7 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants received placebo matched to LY3437943 administered as subcutaneous (SC) injection once-weekly (QW).

Treatment:

Drug: Placebo

1 milligram (mg) LY3437943

Experimental group

Description:

Participants received 1 mg LY3437943 administered as SC injection QW.

Treatment:

Drug: LY3437943

4 mg LY3437943 (2 mg)

Experimental group

Description:

Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 administered as SC injection QW.

Treatment:

Drug: LY3437943

4 mg LY3437943

Experimental group

Description:

Participants received 4 mg LY3437943 administered as SC injection QW.

Treatment:

Drug: LY3437943

8 mg LY3437943 (2 mg)

Experimental group

Description:

Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 and then 8 mg LY3437943 administered as SC injection QW.

Treatment:

Drug: LY3437943

8 mg LY3437943 (4 mg)

Experimental group

Description:

Participants received 4 mg LY3437943 starting dose followed by 8 mg LY3437943 administered as SC injection QW.

Treatment:

Drug: LY3437943

12 mg LY3437943 (2 mg)

Experimental group

Description:

Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943, 8 mg LY3437943 and then 12 mg LY3437943 administered as SC injection QW.

Treatment:

Drug: LY3437943