A Study of LY3437943 in Participants Who Have Obesity or Are Overweight
Condition: Obesity; Overweight
MeSH terms: Obesity; Overweight
Intervention: LY3437943; Placebo
Intervention description: Administered SC; Administered SC
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 338.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Nutritional or Metabolism Disorder; Weight Loss; Overnutrition; Incretins; Hormones; Physiological Effects of Drugs

Summary:

      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.
    

Eligibility criteria:

        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)