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Trial · Interventional

CompletedPhase 1Registry data

A Study of LY3437943 in Postmenopausal Female Participants Who Are Overweight or Obese

NCTNCT06039826 (opens ClinicalTrials.gov in a new tab)Other id18533Other idJ1I-MC-GZBV

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
202320242025
  1. Ph 1

    A Study of LY3437943 in Postmenopausal Female Participants Who Are Overweight or Obese

    NCT06039826

    12 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.

  1. 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

  2. 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

  3. 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

  4. 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

  5. PK: Maximum Observed Concentration (Cmax) of Drospirenone

    Time frame · Predose on Day 1 up to 144 days postdose

    Registry description

    PK: Cmax of Drospirenone

  6. 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
Inclusion Criteria: * Postmenopausal female participants * Body mass index (BMI) within the range 27.0 to 40.0 kilograms per meter squared (kg/m²) Exclusion Criteria: * Have an unstable disease or a disease constituting a risk when taking the study intervention. * Have significant renal insufficiency * Have an important gastro-esophageal reflux disease, pyloric stenosis, gastroparesis or a history of gastric bypass surgery. * Have a history or presence of chronic or idiopathic acute pancreatitis. * Have a history of severe clinically significant multiple or severe drug allergies. * Have a personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia syndrome type 2 * Have had any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin or in situ carcinoma of the cervix that have been resected with no evidence of metastatic disease for 3 years * Have any form of diabetes mellitus other than type 2 * Have type 2 diabetes with HbA1c greater than or equal to 10% at screening * Have received an oral or transdermal patch hormone replacement therapy (HRT) within the last 1 month prior to screening or depot injectable HRT within the last 6 months * Have received any investigational drug within the last month or 5 half-lives of this drug, whichever is longer, prior to screening. If the half-life of the previous investigational drug is unknown, the washout period should be at least 3 months before screening * Show evidence of HIV infection or positive HIV antibodies * Have evidence of, or test positive for, anti-hepatitis C virus antibody unless a confirmatory test for hepatitis C virus RNA is negative * Test positive for hepatitis B surface antigen. In case a hepatitis B virus DNA test was also performed recently and is positive, the participant should be excluded independently of the hepatitis B surface antigen test result. The hepatitis B core antibody test is not used to assess eligibility * Have acute or chronic hepatitis, or signs and symptoms of any other liver disease, or with significant abnormalities in laboratory liver tests * Have a fasting triglyceride level greater than 500 mg/dL at screening * Used any nicotine product including tobacco or nicotine replacement products within 1 month prior to screening or a positive cotinine test at screening. Are unable or unwilling to refrain from using such products during the study * Have donated at least 450 mL of blood within 8 weeks before screening or intend to donate blood during the study

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