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Completed

NCT Number: NCT04172987

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

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.

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Covance Dallas

Dallas, Texas, 75247, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tirzepatide

Drug

Administered SC

Other names: LY3298176

EE/NGM

Drug

Combination oral contraceptive administered orally

Primary outcomes

  1. 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)

    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

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

  2. Period 1 and Period 2, PK: Maximum Concentration (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

    PK: Cmax of EE

  3. Period 1 and Period 2, 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

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

  4. Period 1 and Period 2, 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

    PK: Cmax of Norelgestromin (NGMN)

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Effect of Tirzepatide on Oral Contraceptive Pharmacokinetics in Healthy Female Subjects

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 21, 2019
Registry last updated
Mar 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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