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

Effect of Tirzepatide on Oral Contraceptive Pharmacokinetics in Healthy Female Subjects

Sponsors

Lead Sponsor: Eli Lilly and Company

Source Eli Lilly and Company
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.

Overall Status Recruiting
Start Date February 26, 2020
Completion Date February 11, 2021
Primary Completion Date February 11, 2021
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
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: Maximum Concentration (Cmax) of EE Periods 1 and 2 on Day 21: Pre-dose through 48 hours post-dose
PK: AUC(0-tau) of Norelgestromin (NGMN) Periods 1 and 2 on Day 21: Pre-dose through 24 hours post-dose
PK: Cmax of Norelgestromin (NGMN) Periods 1 and 2 on Day 21: Pre-dose through 48 hours post-dose
Enrollment 42
Condition
Intervention

Intervention Type: Drug

Intervention Name: Tirzepatide

Description: Administered SC

Arm Group Label: EE/NGM + Tirzepatide (Period 2)

Other Name: LY3298176

Intervention Type: Drug

Intervention Name: EE/NGM

Description: Combination oral contraceptive administered orally

Eligibility

Criteria:

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

Gender: Female

Minimum Age: 18 Years

Maximum Age: 45 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
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) Study Director Eli Lilly and Company
Overall Contact

Last Name: This is a single site clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Phone: 1-317-615-4559

Email: [email protected]

Location
Facility: Status: Contact: Investigator: Covance 469-513-6727 Jeanelle Kam Principal Investigator
Location Countries

United States

Verification Date

September 15, 2020

Responsible Party

Type: Sponsor

Has Expanded Access No
Number Of Arms 2
Arm Group

Label: Ethinyl Estradiol + Norgestimate (EE/NGM) Alone (Period 1)

Type: Experimental

Description: 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.)

Label: EE/NGM + Tirzepatide (Period 2)

Type: Experimental

Description: 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).

Patient Data No
Study Design Info

Allocation: Non-Randomized

Intervention Model: Single Group Assignment

Primary Purpose: Basic Science

Masking: None (Open Label)

Source: ClinicalTrials.gov