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

NCT06039826 | Completed Phase 1 FDA Drug

• 2 other identifiers: 18533J1I-MC-GZBV
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Overweight

Keywords

Pharmacokinetics; Obesity; Oral Contraceptive

Outcome Measures

Primary Outcomes (6)

• Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time zero to 24 Hours Postdose (AUC0-24) of Ethinyl Estradiol

  PK: AUC0-24 of Ethinyl Estradiol

  Predose on Day 1 up to 144 days postdose

• PK: Maximum Observed Concentration (Cmax) of Ethinyl Estradiol

  PK: Cmax of Ethinyl Estradiol

  Predose on Day 1 up to 144 days postdose

• PK: Time of Maximum Observed Concentration (Tmax) of Ethinyl Estradiol

  PK: Tmax of Ethinyl Estradiol

  Predose on Day 1 up to 144 days postdose

• PK: Area Under the Concentration Versus Time Curve from Time zero to 24 Hours Postdose (AUC0-24) of Drospirenone

  PK: AUC0-24 of Drospirenone

  Predose on Day 1 up to 144 days postdose

• PK: Maximum Observed Concentration (Cmax) of Drospirenone

  PK: Cmax of Drospirenone

  Predose on Day 1 up to 144 days postdose

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

  PK: Tmax of Drospirenone

  Predose on Day 1 up to 144 days postdose

Study Arms (1)

LY3437943 + Combined Oral Contraceptive (COC)

EXPERIMENTAL

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

Drug: LY3437943; Drug: Ethinyl Estradiol; Drug: Drospirenone

Interventions

LY3437943 DRUG

Administered SC.

LY3437943 + Combined Oral Contraceptive (COC)

Ethinyl Estradiol DRUG

Administered orally

LY3437943 + Combined Oral Contraceptive (COC)

Drospirenone DRUG

Administered orally

LY3437943 + Combined Oral Contraceptive (COC)

Eligibility Criteria

• Age: 40 Years - 60 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Postmenopausal female participants
• Body mass index (BMI) within the range 27.0 to 40.0 kilograms per meter squared (kg/m²)

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (2)

Qps-Mra, Llc

South Miami, Florida, 33143, United States

Location

ICON Early Phase Services

San Antonio, Texas, 78209, United States

Location

MeSH Terms

Conditions

Overweight; Obesity

Interventions

retatrutide; Ethinyl Estradiol; drospirenone

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Norpregnatrienes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estrogenic Steroids, Alkylated; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2023
• First Posted: September 15, 2023
• Study Start: September 12, 2023
• Primary Completion: July 11, 2024
• Study Completion: July 11, 2024
• Last Updated: July 26, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)