Home › Trials › NCT07808060
Clinical trial Recruiting at 2 sites Phase 1 Interventional Ages 18 to 60 Women only

Eloralintide and birth-control pill study in women with overweight or obesity

Official title: 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

Run by Eli Lilly and Company · NCT07808060 · Data updated 2026-11-12

This study tests whether eloralintide affects how oral contraceptives work in women with overweight or obesity.

More Obesity trials

Quick facts

PhasePhase 1
Study typeInterventional
Ages18 Years to 60 Years
SexWomen only
Enrollment34 (estimated)
SponsorEli Lilly and Company
Industry-sponsored
Locations2 sites (Daytona Beach, Florida and 1 other locations)
StatusRecruiting
StartedSeptember 15, 2026
Main results expectedJune 2027
Study endsJune 2027
Registry record updatedOctober 8, 2026
Trial IDNCT07808060 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

AFAB individuals of childbearing potential using non-hormonal contraception or individuals not of childbearing potential, BMI 27–35, stable weight, and normal safety labs.

Probably not a fit

Individuals with contraindications to combined oral contraceptives or uncontrolled liver or thrombotic risks may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 trial in women with obesity or overweight aims to see how eloralintide influences the processing of a combined oral contraceptive. Participants will undergo three CRU stays over about eight months, with each stay lasting 6–8 nights. The study uses oral eloralintide alongside a combined oral contraceptive to examine potential drug–drug interactions and safety in this population. Eligibility requires AFAB individuals of childbearing potential or not of childbearing potential, BMI 27–35, stable weight, and normal safety labs, while excluding those with contraindications to COC.

Why it matters

Potential benefit: If successful, the study could clarify whether eloralintide alters how birth control pills are metabolized in this population, guiding safer co-administration.

How similar studies have gone: Prior studies in related metabolic or obesity drugs have explored interactions with hormonal contraception with mixed results; this study investigates a specific agent with limited prior data.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

  • Fortrea Clinical Research Unit
    Daytona Beach, Florida, United States     Recruiting
  • Fortrea Clinical Research Unit
    Dallas, Texas, United States     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov ↗ Find more trials like this →
Browse more
Obesity 1426Overweight 159Eli Lilly and Company 128
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.