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

Eli Lilly and Company

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.

Eligibility

Age range: 18–60 years
Sex: Female
Healthy volunteers: Yes

Detailed criteria

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 Comb…

Interventions

Drug
Eloralintide
Eloralintide administered SC
Drug
Combined oral contraceptive
levonorgestrel and ethinyl estradiol administered orally

Locations (2)

Fortrea Clinical Research Unit
Daytona Beach, Florida
866-429-3700
Fortrea Clinical Research Unit
Dallas, Texas
866-429-3700

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

Summary

Eligibility

Interventions

Locations (2)

Compensation

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Details

Conditions