Clinical trial NCT06039826: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Overweight
Keywords: Pharmacokinetics
Obesity
Oral Contraceptive
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2023-09-15
Enrollment: 46
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time zero to 24 Hours Postdose (AUC0-24) of Ethinyl Estradiol
timeFrame: Predose on Day 1 up to 144 days postdose
measure: PK: Maximum Observed Concentration (Cmax) of Ethinyl Estradiol
timeFrame: Predose on Day 1 up to 144 days postdose
measure: PK: Time of Maximum Observed Concentration (Tmax) of Ethinyl Estradiol
timeFrame: Predose on Day 1 up to 144 days postdose
measure: PK: Area Under the Concentration Versus Time Curve from Time zero to 24 Hours Postdose (AUC0-24) of Drospirenone
timeFrame: Predose on Day 1 up to 144 days postdose
measure: PK: Maximum Observed Concentration (Cmax) of Drospirenone
timeFrame: Predose on Day 1 up to 144 days postdose
measure: PK: Time of Maximum Observed Concentration (Tmax) of Drospirenone
timeFrame: Predose on Day 1 up to 144 days postdose
Secondary outcomes:
Other outcomes:
Locations:
city: South Miami
country: United States
facility: Qps-Mra, Llc
state: Florida
city: San Antonio
country: United States
facility: ICON Early Phase Services
state: Texas
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: