Obesity, Overweight
Conditions
Brief summary
The main purpose of this study is to evaluate how eloralintide (LY3841136) effects the way the body processes oral contraceptive in female participants with obesity or overweight. For each participant, the study will last about 8 months and will include 3 stays in the Clinical Research Unit (CRU), each lasting between 6 - 8 nights.
Interventions
DRUGEloralintide
Eloralintide administered SC
levonorgestrel and ethinyl estradiol administered orally
Sponsors
Eli Lilly and Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Are individuals AFAB who are individuals of childbearing potential using non-hormonal methods of contraception, or individuals not of childbearing potential. * Have safety laboratory test results within normal reference range for the population or investigative site. * Have a body mass index (BMI) within the range of 27.0 to 35.0 kilograms per square meter (kg/m²), inclusive. * Have had a stable body weight, with less than 5 percent (%) change during the 3-month period prior to screening.
Exclusion criteria
* Have a history or presence of contraindications to the Combined Oral Contraceptive (COC) tablet including thrombosis and the history of any thromboembolic disease, recurrent jaundice, acute or chronic liver disease, hormonally-induced migraines, undiagnosed vaginal bleeding, significant hyperlipidemia, and mammary, endometrial, or hepatic carcinoma (known or suspected). * Have known risks of arterial or venous thrombotic diseases. * Have a significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal (GI), endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs, or of constituting a risk when taking the study drug, or of interfering with the interpretation of data. * Have a known clinically significant gastric emptying abnormality; a GI disorder that impacts GI absorption or gastric emptying; or have undergone weight loss surgery; or have had endoscopic and/or device-based therapy for obesity or device removal within the last 6 months. * Have a history of breast, uterine or ovarian cancer any time or have any malignancy within the past 5 years with the exceptions of basal cell or squamous epithelial carcinomas of the skin, or cervical carcinoma in situ. * Have received drugs that reduce GI motility within 1 month prior to screening. * Have received oral contraceptives within 3 months, implanted contraceptives within 6 months, injectable contraceptives within 12 months, or topical controlled delivery contraceptives (patch) or hormonal intrauterine device within 3 months prior to the study or plan to use during the study. * Have an estimated glomerular filtration rate (eGFR), using the Chronic Kidney Disease Epidemiology Collaboration equation (2021), less than 60.0 milliliter per minute per 1.73 square meters (mL/Minute/1.73m²). * Are pregnant or intend to become pregnant or to breastfeed during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-inf]) of Ethinyl Estradiol and Levonorgestrel | Baseline through Day 128 |
| PK: Maximum Concentration (Cmax) of Ethinyl Estradiol and Levonorgestrel | Baseline through Day 128 |
| PK: Time to Maximum Concentration (Tmax) of Ethinyl Estradiol and Levonorgestrel | Baseline through Day 128 |
Countries
United States
Contacts
CONTACTTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACTPhysicians interested in becoming principal investigators please contact
STUDY_DIRECTORCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Outcome results
None listed