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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-12

Study Completion Date

2024-07-11

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study to Investigate the Effect of AZD6234 and a Combination of AZD9550 and AZD6234 on Pharmacokinetics of Combined Oral Contraceptive Ethinyl Estradiol/Levonorgestrel in Healthy Female Participants Living With Overweight or Obesity

NCT07013643

Healthy Participants

RECRUITING PHASE1

Open-label Study to Evaluate the Efficacy and Safety of an Extended-cycle, Low Dose Combination Oral Contraceptive

NCT00196326

Contraception

COMPLETED PHASE3

A Study of the Effect of Dulaglutide on How the Body Handles Oral Contraceptive in Healthy Female Participants

NCT01458210

Diabetes Mellitus, Type 2

COMPLETED PHASE1

A Study of LY2216684 in Healthy Females

NCT01373931

Depressive Disorder, Major

COMPLETED PHASE1

A Study in Women With Overweight or Obesity to Test Whether Different Doses of BI 456906 Influence the Amount of a Contraceptive in the Blood

NCT05896384

Healthy

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Overweight

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

LY3437943 + Combined Oral Contraceptive (COC)

The COC ethinyl estradiol and drospirenone administered orally in combination with LY3437943 administered subcutaneously (SC).

Group Type EXPERIMENTAL

LY3437943

Intervention Type DRUG

Administered SC.

Ethinyl Estradiol

Intervention Type DRUG

Administered orally

Drospirenone

Intervention Type DRUG

Administered orally

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

LY3437943

Administered SC.

Intervention Type DRUG

Ethinyl Estradiol

Administered orally

Intervention Type DRUG

Drospirenone

Administered orally

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No