ObesityPhase 1NCT07808060
A Study of Eloralintide (LY3841136) in Female Participants With Obesity or Overweight
A Phase 1 study testing Eloralintide and Combined oral contraceptive in people with Obesity and Overweight, run by Eli Lilly and Company at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- Eloralintide and Combined oral contraceptive
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Sep 2026to Jun 2027
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
United States2 sites, 2 recruiting
- Recruiting
Fortrea Clinical Research Unit
Dallas, Texas, 75247
866-429-3700
Archie Bowie
- Recruiting
Fortrea Clinical Research Unit
Daytona Beach, Florida, 32117
866-429-3700
Chiamaka Iheme
About this study
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
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
- Being tested
- Eloralintide, Combined oral contraceptive
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EloralintideDrug
Also called LY3841136
Eloralintide administered SC
Combined oral contraceptiveDrug
levonorgestrel and ethinyl estradiol administered orally
| Study group | Role | What they receive |
|---|---|---|
| Eloralintide and combined oral contraceptive | Experimental | Eloralintide administered subcutaneously (SC), combined oral contraceptive administered orally Receives: Drug: Eloralintide; Drug: Combined oral contraceptive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-inf]) of Ethinyl Estradiol and Levonorgestrel
Measured: Baseline through Day 128
PK: Maximum Concentration (Cmax) of Ethinyl Estradiol and Levonorgestrel
Measured: Baseline through Day 128
PK: Time to Maximum Concentration (Tmax) of Ethinyl Estradiol and Levonorgestrel
Measured: Baseline through Day 128
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start15 Sep 2026
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07808060
- Sponsor's protocol ID
- 27897
- Other IDs
- J3R-MC-YDAU
- Status last verified
- Oct 2026
- First submitted
- 3 Sep 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No