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Not yet recruitingNCT07808060Updated Sep 8, 2026

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

A Phase 1 interventional study of Eloralintide and Combined oral contraceptive in Obesity and Overweight, sponsored by Eli Lilly and Company. Not yet recruiting at 2 sites in United States. Open to female participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-08.

Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
34
Allocation
Not applicable
Ages
18 Years to 60 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Obesity
  • Overweight
03

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
Female
Accepts 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

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.
04

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
34 participants (estimated)

Study arms

  • Experimental
    Eloralintide and combined oral contraceptive

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

    Drug: Eloralintide · Drug: Combined oral contraceptive

Interventions

  • DrugEloralintide

    Eloralintide administered SC

    Also known as: LY3841136

  • DrugCombined oral contraceptive

    levonorgestrel and ethinyl estradiol administered orally

05

What researchers measure

Primary outcomes

  1. 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

  2. PK: Maximum Concentration (Cmax) of Ethinyl Estradiol and Levonorgestrel

    Time frame: Baseline through Day 128

  3. PK: Time to Maximum Concentration (Tmax) of Ethinyl Estradiol and Levonorgestrel

    Time frame: Baseline through Day 128

06

Study locations

2 sites
  • Fortrea Clinical Research Unit
    Daytona Beach, Florida 32117, United States
    • · Contact · 866-429-3700
    • Chiamaka Iheme · Principal investigator
  • Fortrea Clinical Research Unit
    Dallas, Texas 75247, United States
    • · Contact · 866-429-3700
    • Archie Bowie · Principal investigator
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07808060
Lead sponsor
Eli Lilly and Company
Responsible party
Sponsor
First posted
Sep 8, 2026
Start date
Sep 2026 (estimated)
Primary completion
Jun 2027 (estimated)
Completion
Jun 2027 (estimated)
Last update
Sep 8, 2026

Study contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Contact
LillyTrials@Lilly.com
1-317-615-4559
Physicians interested in becoming principal investigators please contact
Contact
clinical_inquiry_hub@lilly.com
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)
study director · Eli Lilly and Company

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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