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

Phase 1

Completed

• Conditions: Overweight
• Interventions: Drug: LY3437943; Drug: Ethinyl Estradiol; Drug: Drospirenone

• Registration Number: NCT06039826
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-11
• Study First Submitted QC: 2023-09-11
• Study Start: 2023-09-12
• Study First Posted: 2023-09-15
• Status Verified: 2024-07
• Primary Completion: 2024-07-11
• Study Completion: 2024-07-11
• Last Update Submitted: 2024-07-25
• Last Update Posted: 2024-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 46

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
LY3437943 + Combined Oral Contraceptive (COC)	LY3437943	The COC ethinyl estradiol and drospirenone administered orally in combination with LY3437943 administered subcutaneously (SC).
LY3437943 + Combined Oral Contraceptive (COC)	Ethinyl Estradiol	The COC ethinyl estradiol and drospirenone administered orally in combination with LY3437943 administered subcutaneously (SC).
LY3437943 + Combined Oral Contraceptive (COC)	Drospirenone	The COC ethinyl estradiol and drospirenone administered orally in combination with LY3437943 administered subcutaneously (SC).

Primary Outcome Measures

Name	Time	Method
PK: Time of Maximum Observed Concentration (Tmax) of Ethinyl Estradiol	Predose on Day 1 up to 144 days postdose	PK: Tmax of Ethinyl Estradiol
PK: Maximum Observed Concentration (Cmax) of Drospirenone	Predose on Day 1 up to 144 days postdose	PK: Cmax of Drospirenone
PK: Time of Maximum Observed Concentration (Tmax) of Drospirenone	Predose on Day 1 up to 144 days postdose	PK: Tmax of Drospirenone
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time zero to 24 Hours Postdose (AUC0-24) of Ethinyl Estradiol	Predose on Day 1 up to 144 days postdose	PK: AUC0-24 of Ethinyl Estradiol
PK: Maximum Observed Concentration (Cmax) of Ethinyl Estradiol	Predose on Day 1 up to 144 days postdose	PK: Cmax of Ethinyl Estradiol
PK: Area Under the Concentration Versus Time Curve from Time zero to 24 Hours Postdose (AUC0-24) of Drospirenone	Predose on Day 1 up to 144 days postdose	PK: AUC0-24 of Drospirenone

Trial Locations

Locations (2)

Qps-Mra, Llc; 🇺🇸 South Miami, Florida, United States

ICON Early Phase Services; 🇺🇸 San Antonio, Texas, United States