CompletedPhase 1

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

A Phase 1 Study to Investigate the Effect of LY3437943 on the Pharmacokinetics of the Combined Oral Contraceptive Ethinyl Estradiol and Drospirenone in Female Participants

Lead sponsor

Eli Lilly and Company

Asset

Retatrutide

Subcutaneous · GLP-1 / GIP / glucagon triple

Listed sites

Recruiting sites

Actual enrollment

Study population

Obesity / overweight

Eligibility highlights

•BMI 27-40•Female

Primary endpoints

•AUC from Time zero•PK: Maximum Observed Concentration (Cmax) of Ethinyl Estradiol•PK: Time of Maximum Observed Concentration (Tmax) of Ethinyl Estradiol

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06039826

Org study ID18533

Secondary IDJ1I-MC-GZBVEli Lilly and Company

Timeline

Milestones

Study start2023-09-12actual

Study first posted2023-09-15actual

Primary completion2024-07-11actual

Study completion2024-07-11actual

Last update posted2024-07-26actual

Assets

Investigational agents

Retatrutide

Who this study enrolls

Obesity / overweight

Who can enroll

Minimum age40 Years

Maximum age60 Years

SexFemale

Healthy volunteersNot accepted

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

Endpoints (6)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

6 endpoints

Primary/protocol endpoint

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time zero to 24 Hours Postdose (AUC0-24) of Ethinyl Estradiol