A Study of LY3437943 in Postmenopausal Female Participants Who Are Overweight or Obese
Part of paid clinical trials in South Miami, Florida.
- Sponsor
- Eli Lilly and Company
- Study ID
- NCT06039826
- Phase
- PHASE1
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- FEMALE
- Age
- 40 Years - 60 Years
- Healthy Volunteers
- Not accepted
Interventions
- LY3437943 — DRUGAdministered SC.
- Ethinyl Estradiol — DRUGAdministered orally
- Drospirenone — DRUGAdministered orally
Study Details
The main purpose of this study is to determine the effect of LY3437943 when administered subcutaneously on the levels of combined oral contraceptive (COC) ethinyl estradiol and drospirenone in the blood stream in postmenopausal female participants who are overweight or obese. The safety and tolerability of LY3437943 when administered with COC will also be evaluated. This study will last up to approximately 29 weeks for each participant.
Key Dates
- Start date
- Sep 12, 2023
- Status verified
- Jul 2024
- Primary completion
- Jul 11, 2024
- Completion
- Jul 11, 2024
Study Design
- Enrollment
- 46 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SEQUENTIAL
- Primary purpose
- BASIC_SCIENCE
Arms
- Experimental: LY3437943 + Combined Oral Contraceptive (COC)The COC ethinyl estradiol and drospirenone administered orally in combination with LY3437943 administered subcutaneously (SC).
Primary Outcome Measure
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time zero to 24 Hours Postdose (AUC0-24) of Ethinyl Estradiol [ Time Frame: Predose on Day 1 up to 144 days postdose ]
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Qps-Mra, Llc | South Miami | Florida | 33143 | - |
| ICON Early Phase Services | San Antonio | Texas | 78209 | - |
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