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

NCT07808060 | Not Yet Recruiting Phase 1 FDA Drug

• 2 other identifiers: 27897J3R-MC-YDAU
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Eloralintide and combined oral contraceptive

EXPERIMENTAL

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

Drug: Eloralintide; Drug: Combined oral contraceptive

Interventions

Eloralintide DRUG

Eloralintide administered SC

Also known as: LY3841136

Eloralintide and combined oral contraceptive

Combined oral contraceptive DRUG

levonorgestrel and ethinyl estradiol administered orally

Eloralintide and combined oral contraceptive

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: Individuals assigned female at birth (AFAB)
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (2)

Fortrea Clinical Research Unit

Daytona Beach, Florida, 32117, United States

Location

Fortrea Clinical Research Unit

Dallas, Texas, 75247, United States

Location

MeSH Terms

Conditions

Obesity; Overweight

Interventions

Contraceptives, Oral, Combined

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Combinations; Pharmaceutical Preparations; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptive Agents; Reproductive Control Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses

Study Officials

• Call 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

  STUDY DIRECTOR

Central Study Contacts

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

CONTACT

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

Physicians interested in becoming principal investigators please contact

CONTACT

clinical_inquiry_hub@lilly.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2026
• First Posted: September 8, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: September 8, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)