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

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT04172987
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
11.5
Actual Duration (Months)
3.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Effect of Tirzepatide on Oral Contraceptive Pharmacokinetics in Healthy Female Subjects
Actual Study Start Date :
Feb 26, 2020
Actual Primary Completion Date :
Feb 9, 2021
Actual Study Completion Date :
Feb 9, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Ethinyl Estradiol + Norgestimate (EE/NGM) Alone (Period 1)

EE and NGM (active tablets) administered orally for 21 days, then non-active tablets administered orally for 7 days. (1 course of oral contraceptive = 28 days.)

Drug: EE/NGM
Combination oral contraceptive administered orally
Experimental: EE/NGM + Tirzepatide (Period 2)

EE and NGM (active tablets) administered orally for 21 days, then non-active tablets administered orally for 7 days. (1 course of oral contraceptive = 28 days.) Tirzepatide administered by subcutaneous injection (SC).

Drug: Tirzepatide
Administered SC
Other Names:
  • LY3298176

    • Drug: EE/NGM
    Combination oral contraceptive administered orally

    Outcome Measures

    Primary Outcome Measures

    1. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) Within 1 Dosing Interval (AUC[0-tau]) of Ethinylestradiol (EE) [Periods 1 and 2 on Day 21: Pre-dose through 24 hours post-dose]

      PK: AUC(0-tau) of EE

    2. PK: Maximum Concentration (Cmax) of EE [Periods 1 and 2 on Day 21: Pre-dose through 48 hours post-dose]

      PK: Cmax of EE

    3. PK: AUC(0-tau) of Norelgestromin (NGMN) [Periods 1 and 2 on Day 21: Pre-dose through 24 hours post-dose]

      PK: AUC(0-tau) of NGMN

    4. PK: Cmax of Norelgestromin (NGMN) [Periods 1 and 2 on Day 21: Pre-dose through 48 hours post-dose]

      PK: Cmax of NGMN

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Covance Dallas Dallas Texas United States 75247

    Sponsors and Collaborators

    • Eli Lilly and Company

    Investigators

    • Study Director: 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT04172987
    Other Study ID Numbers:
    • 17103
    • I8F-MC-GPGR
    First Posted:
    Nov 21, 2019
    Last Update Posted:
    Feb 18, 2021
    Last Verified:
    Feb 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Tirzepatide

    Study Results

    No Results Posted as of Feb 18, 2021