NCT06039826CompletedPhase 1
A Study of LY3437943 in Postmenopausal Female Participants Who Are Overweight or Obese
A Phase 1 Study to Investigate the Effect of LY3437943 on the Pharmacokinetics of the Combined Oral Contraceptive Ethinyl Estradiol and Drospirenone in Female Participants
Source: ClinicalTrials.gov · Last updated 26 Jul 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 46 (actual)
- First submitted
- 11 Sept 2023
- Start date
- 12 Sept 2023
- Primary completion date
- 11 Jul 2024
- Lead sponsor
- Eli Lilly and Company
- Diseases
- Obesity
- NCT number
- NCT06039826
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 46
- From 12 Sept 2023 to the primary completion date, 11 Jul 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- 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
Other illness
- 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 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
- 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
Lab values
- Have type 2 diabetes with HbA1c greater than or equal to 10% at screening
- 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
Other
- Have a history or presence of chronic or idiopathic acute pancreatitis.
Who the study is looking for
- Postmenopausal female participants
- Body mass index (BMI) within the range 27.0 to 40.0 kilograms per meter squared (kg/m²)
Age in the registry: 40 years to 60 years · Sex: Female · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| ICON Early Phase Services Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Qps-Mra, Llc Coordinator of this site? Confirm its status | South Miami | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.