A Study of the Effect of Tirzepatide on How the Body Handles Birth Control Pills in Healthy Female Participants

Eli Lilly and Company40 enrolled

Overview

The purpose of this study is to look at how the body processes the commonly prescribed birth control pill, ethinylestradiol + norgestimate (EE/NGM), in healthy female participants and the effect of tirzepatide on how EE/NGM is processed by the body. Information about any side effects that may occur will also be collected. Screening is required within 28 days prior to the start of the study. For each participant, the study will last about 20 weeks, including screening.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

TirzepatideDRUG

Administered SC

EE/NGMDRUG

Combination oral contraceptive administered orally

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Overtly healthy females as determined by medical history, physical examination, and other screening procedures * Have a body mass index (BMI) equal to or above 18.5 kilograms per meter squared (kg/m²), at screening * Are not intending to start a family within 2 months after the study Exclusion Criteria: * Have known allergies to either tirzepatide or ethinylestradiol or norgestimate or related compounds * Have a medical condition or medical history that precludes the taking of combined oral contraceptives * Have a history or presence of pancreatitis (history of chronic pancreatitis or idiopathic acute pancreatitis), elevation in serum amylase or lipase or gastrointestinal (GI) disorder (eg, relevant esophageal reflux or gall bladder disease) or any GI disease which impacts gastric emptying (eg, gastric bypass surgery, pyloric stenosis, with the exception of appendectomy) or could be aggravated by glucagon-like peptide-1 (GLP-1) analogs or dipeptidyl peptidase IV (DPP-IV) inhibitors * Have used hormonal implants or received hormonal injections in the past 12 months * Unwilling to comply with smoking restrictions during the study * Is a known user of drugs of abuse

Locations (1)

Covance Dallas

Dallas, Texas, United States

Outcomes

Primary Outcomes

Period 1 and Period 2, Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) Within 1 Dosing Interval (AUC[0-tau]) of Ethinylestradiol (EE)

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) Within 1 Dosing Interval (AUC\[0-tau\]) of Ethinylestradiol (EE)

Time frame: Period 1 and Period 2: Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 48 hours postdose

Period 1 and Period 2, PK: Maximum Concentration (Cmax) of EE

PK: Cmax of EE

Time frame: Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 48 hours postdose

Period 1 and Period 2, PK: Area Under the Concentration Versus Time Curve (AUC) Within 1 Dosing Interval (AUC[0-tau]) of Norelgestromin (NGMN)

PK: Area Under the Concentration Versus Time Curve (AUC) Within 1 Dosing Interval (AUC\[0-tau\]) of Norelgestromin (NGMN)

Time frame: Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 48 hours postdose

Period 1 and Period 2, PK: Cmax of Norelgestromin (NGMN)

PK: Cmax of Norelgestromin (NGMN)

Time frame: Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 48 hours postdose

Data from ClinicalTrials.gov

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