HealthyPhase 1NCT04172987

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

A Phase 1 study testing Tirzepatide and EE/NGM in people with Healthy, run by Eli Lilly and Company at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Tirzepatide and EE/NGM
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteUnited States
Study dates: 26 Feb 2020to 9 Feb 2021
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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 locations and contacts

1 site in 1 country.

United States1 site

Covance Dallas
Dallas, Texas, 75247

Other trials in United States

About this study

Official title: Effect of Tirzepatide on Oral Contraceptive Pharmacokinetics in Healthy Female Subjects

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.

Conditions: Healthy
Being tested: Tirzepatide, EE/NGM

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TirzepatideDrug
Also called LY3298176
Administered SC
EE/NGMDrug
Combination oral contraceptive administered orally

Study groups in NCT04172987
Study group	Role	What they receive
Ethinyl Estradiol + Norgestimate (EE/NGM) Alone (Period 1)	Experimental	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. Receives: Drug: EE/NGM
EE/NGM + Tirzepatide (Period 2)	Experimental	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). Receives: Drug: Tirzepatide; Drug: EE/NGM

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Feb 20209 Feb 2021

First posted21 Nov 2019
Study start26 Feb 2020
Primary completion9 Feb 2021
Study completion9 Feb 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04172987
Sponsor's protocol ID: 17103
Other IDs: I8F-MC-GPGR
Status last verified: Jun 2022
First submitted: 20 Nov 2019
Last updated: 27 Mar 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 27 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Tirzepatide on Oral Contraceptive Pharmacokinetics in Healthy Female Subjects
ClinicalTrials.gov ID: NCT04172987
Acronym / sponsor ID: 17103
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: 26 Feb 2020 (actual)
Primary completion: 9 Feb 2021 (actual)
Study completion: 9 Feb 2021 (actual)
First posted: 21 Nov 2019 (actual)
Results: Posted 27 Mar 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Ethinyl Estradiol + Norgestimate (EE/NGM) Alone (Period 1)	Experimental	Drug: EE/NGMParticipants 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.
EE/NGM + Tirzepatide (Period 2)	Experimental	Drug: Tirzepatide, Drug: EE/NGMParticipants 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).

Who may qualify

Ages: 18 to 45 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TirzepatideAlso: LY3298176Administered SC	Drug	EE/NGM + Tirzepatide (Period 2)
EE/NGMCombination oral contraceptive administered orally	Drug	EE/NGM + Tirzepatide (Period 2), Ethinyl Estradiol + Norgestimate (EE/NGM) Alone (Period 1)

Primary outcome

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)
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
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)
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)

Results and safety

Results posted to the registry on 27 Mar 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Overall Study	40	38

Primary outcome: 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. Geometric mean (Geometric Coefficient of Variation). Unit: picogram hour per milliliter (pg*h/mL)

Measure	OC (0.035 mg EE and 0.25 mg NGM) n = 35	OC (0.035 mg EE and 0.25 mg NGM) + 5 mg Tirzepatide n = 21
Value	966 (40)	811 (41)

Population analysed: Period 1 and Period 2: All participants who received at least one dose of oral contraceptive or tirzepatide and had evaluable PK data.

Primary outcome: 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. Geometric mean (Geometric Coefficient of Variation). Unit: picogram per milliliter pg/mL

Measure	OC (0.035 mg EE and 0.25 mg NGM) n = 35	OC (0.035 mg EE and 0.25 mg NGM) + 5 mg Tirzepatide n = 24
Value	119 (33)	49.6 (63)

Population analysed: Period 1 and Period 2: All participants who received at least one dose of oral contraceptive or tirzepatide and had evaluable PK data.

Primary outcome: 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. Geometric mean (Geometric Coefficient of Variation). Unit: pg*h/mL

Measure	OC (0.035 mg EE and 0.25 mg NGM) n = 35	OC (0.035 mg EE and 0.25 mg NGM) + 5 mg Tirzepatide n = 26
Value	19900 (27)	14600 (67)

Population analysed: Period 1 and Period 2: All participants who received at least one dose of oral contraceptive or tirzepatide and had evaluable PK data.

Primary outcome: 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. Geometric mean (Geometric Coefficient of Variation). Unit: pg/mL

Measure	OC (0.035 mg EE and 0.25 mg NGM) n = 35	OC (0.035 mg EE and 0.25 mg NGM) + 5 mg Tirzepatide n = 26
Value	2070 (27)	892 (74)

Population analysed: Period 1 and Period 2: All participants who received at least one dose of oral contraceptive or tirzepatide and had evaluable PK data.

Adverse events

Time frame: Lead-In Up To 15 Weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lead-in: OC ( 0.035 mg EE and 0.25 mg NGM)	0 of 40 (0%)	9 of 40 (22.5%)	0 of 40
Period 1: OC ( 0.035 mg EE and 0.25 mg NGM)	0 of 38 (0%)	10 of 38 (26.3%)	0 of 38
Period 2: OC ( 0.035 mg EE and 0.25 mg NGM) + 5 mg Tirzepatide	0 of 28 (0%)	18 of 28 (64.3%)	0 of 28

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Tirzepatide and EE/NGM in people with Healthy, run by Eli Lilly and Company at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04172987.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2023.