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

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: EE/NGM; Drug: Tirzepatide

Study type: Interventional

Funder types: Industry

Identifiers

NCT04172987

I8F-MC-GPGR (Other Identifier)

17103

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

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

Experimental group

Description:

Participants received a 28-day packet of a combination oral contraceptive (OC) containing 21 days of tablets that consist of active ingredients (0.035 mg ethinyl estradiol (EE) and 0.25 mg norgestimate (NGM)) self-administered orally once-daily (QD) on Day 1 to Day 21, and 7 days of non-active tablets self-administer orally QD on Day 22 to Day 28 approximately the same time each day.

Treatment:

Drug: EE/NGM

EE/NGM + Tirzepatide (Period 2)

Experimental group

Description:

Participants received a 28-day packet of a combination OC containing 21 days of tablets that consist of active ingredients (0.035 mg EE and 0.25 mg NGM) self-administered orally QD on Day 1 to Day 21, and 7 days of non-active tablets self-administer orally QD on Day 22 to Day 28 approximately the same time each day and a single dose 5 mg tirzepatide administered subcutaneously (SC).

Treatment:

Drug: Tirzepatide

Drug: EE/NGM