Trial · Interventional
CompletedPhase 1Registry dataA Study of LY3437943 in Postmenopausal Female Participants Who Are Overweight or Obese
Overview
- Status
- Completed
- Phase
- Phase 1
- Enrollment
- 46 participants (actual)
- Sponsor
- Eli Lilly and Company · Industry
- Design
- Not randomized · Open label (no masking)
- Countries
1 country
United States
- Start
- 12 Sept 2023
- Primary completion
- 11 Jul 2024
- Completion
- 11 Jul 2024
- First posted
- 15 Sept 2023
- Last update posted
- 26 Jul 2024
- Conditions
- Overweight
Timeline
1 trial · 1 completed
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 1
A Study of LY3437943 in Postmenopausal Female Participants Who Are Overweight or Obese
NCT0603982612 Sept 2023 to 11 Jul 2024
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- LY3437943Drug
- Ethinyl EstradiolDrug
- DrospirenoneDrug
Arms1
Experimental
LY3437943 + Combined Oral Contraceptive (COC)
The COC ethinyl estradiol and drospirenone administered orally in combination with LY3437943 administered subcutaneously (SC).
Primary outcomes6
Outcomes the sponsor listed as primary.
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
Registry description
PK: AUC0-24 of Ethinyl Estradiol
PK: Maximum Observed Concentration (Cmax) of Ethinyl Estradiol
Time frame · Predose on Day 1 up to 144 days postdose
Registry description
PK: Cmax of Ethinyl Estradiol
PK: Time of Maximum Observed Concentration (Tmax) of Ethinyl Estradiol
Time frame · Predose on Day 1 up to 144 days postdose
Registry description
PK: Tmax of Ethinyl Estradiol
PK: Area Under the Concentration Versus Time Curve from Time zero to 24 Hours Postdose (AUC0-24) of Drospirenone
Time frame · Predose on Day 1 up to 144 days postdose
Registry description
PK: AUC0-24 of Drospirenone
PK: Maximum Observed Concentration (Cmax) of Drospirenone
Time frame · Predose on Day 1 up to 144 days postdose
Registry description
PK: Cmax of Drospirenone
PK: Time of Maximum Observed Concentration (Tmax) of Drospirenone
Time frame · Predose on Day 1 up to 144 days postdose
Registry description
PK: Tmax of Drospirenone
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
Completed trials do not always post results.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- Female
- Age
- from 40 Years up to 60 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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