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

ConditionsObesityOverweight
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age18-60
SponsorEli Lilly and Company

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Eloralintide

    Drug

    Eloralintide administered SC

  • Combined oral contraceptive

    Drug

    levonorgestrel and ethinyl estradiol administered orally

Treatment groups

34 Participants
are divided into 1 treatment group
Group A: Eloralintide and combined oral contraceptiveExperimental treatment 2 interventions

Trial outcomes

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eli Lilly and Company

Lead sponsor

Source ClinicalTrials.gov
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