A Study of LY3437943 in Postmenopausal Female Participants Who Are Overweight or Obese

Lilly

Status and phase

Completed

Phase 1

Conditions

Overweight

Treatments

Drug: LY3437943

Drug: Ethinyl Estradiol

Drug: Drospirenone

Study type

Interventional

Funder types

Industry

Identifiers

NCT06039826

18533

J1I-MC-GZBV (Other Identifier)

Details and patient eligibility

About

The main purpose of this study is to determine the effect of LY3437943 when administered subcutaneously on the levels of combined oral contraceptive (COC) ethinyl estradiol and drospirenone in the blood stream in postmenopausal female participants who are overweight or obese. The safety and tolerability of LY3437943 when administered with COC will also be evaluated. This study will last up to approximately 29 weeks for each participant.

Enrollment

46 patients

Sex

Female

Ages

40 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Postmenopausal female participants
Body mass index (BMI) within the range 27.0 to 40.0 kilograms per meter squared (kg/m²)

Exclusion criteria

Have an unstable disease or a disease constituting a risk when taking the study intervention.
Have significant renal insufficiency
Have an important gastro-esophageal reflux disease, pyloric stenosis, gastroparesis or a history of gastric bypass surgery.
Have a history or presence of chronic or idiopathic acute pancreatitis.
Have a history of severe clinically significant multiple or severe drug allergies.
Have a personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia syndrome type 2
Have had any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin or in situ carcinoma of the cervix that have been resected with no evidence of metastatic disease for 3 years
Have any form of diabetes mellitus other than type 2
Have type 2 diabetes with HbA1c greater than or equal to 10% at screening
Have received an oral or transdermal patch hormone replacement therapy (HRT) within the last 1 month prior to screening or depot injectable HRT within the last 6 months
Have received any investigational drug within the last month or 5 half-lives of this drug, whichever is longer, prior to screening. If the half-life of the previous investigational drug is unknown, the washout period should be at least 3 months before screening
Show evidence of HIV infection or positive HIV antibodies
Have evidence of, or test positive for, anti-hepatitis C virus antibody unless a confirmatory test for hepatitis C virus RNA is negative
Test positive for hepatitis B surface antigen. In case a hepatitis B virus DNA test was also performed recently and is positive, the participant should be excluded independently of the hepatitis B surface antigen test result. The hepatitis B core antibody test is not used to assess eligibility
Have acute or chronic hepatitis, or signs and symptoms of any other liver disease, or with significant abnormalities in laboratory liver tests
Have a fasting triglyceride level greater than 500 mg/dL at screening
Used any nicotine product including tobacco or nicotine replacement products within 1 month prior to screening or a positive cotinine test at screening. Are unable or unwilling to refrain from using such products during the study
Have donated at least 450 mL of blood within 8 weeks before screening or intend to donate blood during the study