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

Primary Purpose

Overweight

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
LY3437943
Ethinyl Estradiol
Drospirenone
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Overweight focused on measuring Pharmacokinetics, Obesity, Oral Contraceptive

Eligibility Criteria

40 Years - 60 Years (Adult)FemaleDoes not accept 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

Sites / Locations

  • Qps-Mra, LlcRecruiting
  • ICON Early Phase ServicesRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

LY3437943 + Combined Oral Contraceptive (COC)

Arm Description

The COC ethinyl estradiol and drospirenone administered orally in combination with LY3437943 administered subcutaneously (SC).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 11, 2023
Last Updated
October 10, 2023
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT06039826
Brief Title
A Study of LY3437943 in Postmenopausal Female Participants Who Are Overweight or Obese
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 12, 2023 (Actual)
Primary Completion Date
January 2, 2025 (Anticipated)
Study Completion Date
January 2, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight
Keywords
Pharmacokinetics, Obesity, Oral Contraceptive

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
39 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LY3437943 + Combined Oral Contraceptive (COC)
Arm Type
Experimental
Arm Description
The COC ethinyl estradiol and drospirenone administered orally in combination with LY3437943 administered subcutaneously (SC).
Intervention Type
Drug
Intervention Name(s)
LY3437943
Intervention Description
Administered SC.
Intervention Type
Drug
Intervention Name(s)
Ethinyl Estradiol
Intervention Description
Administered orally
Intervention Type
Drug
Intervention Name(s)
Drospirenone
Intervention Description
Administered orally
Primary Outcome Measure Information:
Title
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time zero to 24 Hours Postdose (AUC0-24) of Ethinyl Estradiol
Description
PK: AUC0-24 of Ethinyl Estradiol
Time Frame
Predose on Day 1 up to 144 days postdose
Title
PK: Maximum Observed Concentration (Cmax) of Ethinyl Estradiol
Description
PK: Cmax of Ethinyl Estradiol
Time Frame
Predose on Day 1 up to 144 days postdose
Title
PK: Time of Maximum Observed Concentration (Tmax) of Ethinyl Estradiol
Description
PK: Tmax of Ethinyl Estradiol
Time Frame
Predose on Day 1 up to 144 days postdose
Title
PK: Area Under the Concentration Versus Time Curve from Time zero to 24 Hours Postdose (AUC0-24) of Drospirenone
Description
PK: AUC0-24 of Drospirenone
Time Frame
Predose on Day 1 up to 144 days postdose
Title
PK: Maximum Observed Concentration (Cmax) of Drospirenone
Description
PK: Cmax of Drospirenone
Time Frame
Predose on Day 1 up to 144 days postdose
Title
PK: Time of Maximum Observed Concentration (Tmax) of Drospirenone
Description
PK: Tmax of Drospirenone
Time Frame
Predose on Day 1 up to 144 days postdose

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Phone
1-317-615-4559
Email
ClinicalTrials.gov@Lilly.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Qps-Mra, Llc
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
305-722-0970 ext 5207
First Name & Middle Initial & Last Name & Degree
Sandra Pagnussat
Facility Name
ICON Early Phase Services
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
210-283-4120
First Name & Middle Initial & Last Name & Degree
Cassandra Key

12. IPD Sharing Statement

Plan to Share IPD
No

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

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