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RecruitingPhase 1

A Study of Eloralintide (LY3841136) in Female Participants With Obesity or Overweight

A Phase 1, Open-Label Study to Evaluate the Effect of Eloralintide on the Pharmacokinetics of the Combined Oral Contraceptive Levonorgestrel-Ethinyl Estradiol in Female Participants With Obesity or Overweight

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 60 Years
Sex
Female only
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how eloralintide (LY3841136) affects the way the body processes birth control pills. It is for people assigned female at birth who have overweight or obesity. The study lasts about 8 months and includes 3 stays at a research unit, each lasting 6 to 8 nights.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Were assigned female at birth. If you can become pregnant, you must use birth control without hormones.
  • Have safety lab test results in the normal range.
  • Have a body mass index (BMI) of 27 to 35. BMI is a measure based on height and weight.
  • Have had less than a 5% change in body weight during the 3 months before screening.

Who can't join

  • Have a condition that makes combined birth control pills unsafe, such as blood clots, repeated yellowing of the skin or eyes, liver disease, migraines caused by hormones, unexplained vaginal bleeding, very high blood fats, or known or suspected breast, uterine lining, or liver cancer.
  • Have known risks for blood clots in arteries or veins.
  • Have a serious past or current illness that could affect how your body handles drugs, make the study drug unsafe, or affect study results. Also excluded: an eGFR below 60, a test result showing reduced kidney function.
  • Have a major problem with stomach emptying or a gut condition that affects food or drug absorption or stomach emptying. Have had weight-loss surgery, or obesity treatment using a scope or device, or device removal, within the past 6 months.
  • Have ever had breast, uterine, or ovarian cancer, or had another cancer in the past 5 years. Exceptions include basal cell or squamous cell skin cancer and cervical cancer that has not spread beyond the surface layer.
  • Used drugs that slow movement through the stomach or gut within 1 month before screening.
  • Used hormonal birth control before the study: pills within 3 months, implants within 6 months, shots within 12 months, or patches or hormonal IUDs within 3 months. An IUD is a small device placed in the uterus. Planning to use these during the study also excludes you.
  • Are pregnant, plan to become pregnant, or plan to breastfeed during the study.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (2)

FL

TX