Current partner codePEPTIDESDE
NCT06039826·Phase 1·INTERVENTIONAL

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

Status

Completed

Phase

Phase 1

Enrollment

46

Locations

2

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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

Treatment arms and agents.

DRUG

LY3437943

Administered SC.

DRUG

Ethinyl Estradiol

Administered orally

DRUG

Drospirenone

Administered orally

Timeline

From registration to results.

  1. First posted

    Sep 15, 2023

  2. Study start

    Sep 12, 2023

  3. Primary completion

    Jul 11, 2024

  4. Study completion

    Jul 11, 2024

  5. Results posted

    Not reported

  6. Registry updated

    Jul 26, 2024

Outcomes

What the study measures.

Primary outcomes

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

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

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

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

PK: AUC0-24 of Drospirenone

PK: Maximum Observed Concentration (Cmax) of Drospirenone

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

PK: Cmax of Drospirenone

PK: Time of Maximum Observed Concentration (Tmax) of Drospirenone

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

PK: Tmax of Drospirenone

Secondary outcomes

Not reported in the indexed record.

Eligibility

Who can take part.

Minimum age
40 Years
Maximum age
60 Years
Sex
FEMALE
Healthy volunteers
No

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

Study locations

2 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Qps-Mra, Llc

South Miami, Florida, United States

ICON Early Phase Services

San Antonio, Texas, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

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