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

July 25, 2024 updated by: Eli Lilly and Company

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • South Miami, Florida, United States, 33143
        • Qps-Mra, Llc
    • Texas
      • San Antonio, Texas, United States, 78209
        • ICON Early Phase Services

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LY3437943 + Combined Oral Contraceptive (COC)
The COC ethinyl estradiol and drospirenone administered orally in combination with LY3437943 administered subcutaneously (SC).
Drug: LY3437943
Administered SC.
Drug: Ethinyl Estradiol
Administered orally
Drug: Drospirenone
Administered orally

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Investigators

  • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 12, 2023

Primary Completion (Actual)

July 11, 2024

Study Completion (Actual)

July 11, 2024

Study Registration Dates

First Submitted

September 11, 2023

First Submitted That Met QC Criteria

September 11, 2023

First Posted (Actual)

September 15, 2023

Study Record Updates

Last Update Posted (Actual)

July 26, 2024

Last Update Submitted That Met QC Criteria

July 25, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18533
  • J1I-MC-GZBV (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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