Recruiting
Phase 1

Eloralintide

Sponsor:

Eli Lilly and Company

Code:

NCT07808060

Conditions

Obesity

Overweight

Eligibility Criteria

Sex: Female

Age: 18 - 60

Healthy Volunteers: Accepted

Interventions

Eloralintide

Combined oral contraceptive

Study Details

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.

Conditions

Obesity

Overweight

Study ID

NCT07808060

Start date

Sep 15, 2026

Status verified date

Oct, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 60

Healthy Volunteers: Accepted

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 Design

Enrollment

34 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Eloralintide and combined oral contraceptive

Eloralintide administered subcutaneously (SC), combined oral contraceptive administered orally

Interventions

Eloralintide

Eloralintide administered SC

Combined oral contraceptive

levonorgestrel and ethinyl estradiol administered orally

Primary outcome measure

  • Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-inf]) of Ethinyl Estradiol and Levonorgestrel [ Time Frame: Baseline through Day 128 ]
  • PK: Maximum Concentration (Cmax) of Ethinyl Estradiol and Levonorgestrel [ Time Frame: Baseline through Day 128 ]
  • PK: Time to Maximum Concentration (Tmax) of Ethinyl Estradiol and Levonorgestrel [ Time Frame: Baseline through Day 128 ]

Central Contacts and Locations

Central contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

1-317-615-4559LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

Locations

Fortrea Clinical Research Unit

Recruiting

Daytona Beach, Florida, United States, 32117

Contacts

866-429-3700

Principal Investigator:

Chiamaka Iheme

Fortrea Clinical Research Unit

Recruiting

Dallas, Texas, United States, 75247

Contacts

866-429-3700

Principal Investigator:

Archie Bowie

More Information

Sponsor

Eli Lilly and Company

Last update posted

Oct 8, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-09. This information was provided to ClinicalTrials.gov by Eli Lilly and Company on 2026-10-08. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.