OverweightPhase 1NCT04407234

A Study to Measure Stomach Emptying in Overweight Non-diabetic and Diabetic Participants Using Tirzepatide

A Phase 1 study testing Tirzepatide and Acetaminophen in people with Overweight and Obesity, 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 learn more about how tirzepatide affects stomach emptying in overweight/very overweight participants. Participants include those without diabetes and those with type 2 diabetes. The study will last about 13 weeks for each participant, including screening. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Overweight, Obesity, Diabetes Mellitus, Type 2
What is being tested?: Tirzepatide and Acetaminophen
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: 1 siteUnited States
Study dates: 15 Sep 2020to 7 Jan 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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Have a body mass index (BMI) between 27 to 45 kilograms per meter squared (kg/m²), inclusive at screening
For nondiabetic subjects: as determined by medical history, physical examination, and safety assessments at screening
For participants with a confirmed type 2 diabetes diagnosis: The condition must be managed either by diet and exercise alone or on a stable dose of metformin for the past 3 months
Willing and agreeable to commit to the duration of the study and undergo study procedures as instructed by the clinic staff

Who cannot join

Have undergone gastric bypass or bariatric surgery
Have received prescription drugs or over the counter drugs that promote weight loss in the past 6 months prior to screening
For participants with a confirmed type 2 diabetes diagnosis: Have experienced more than 1 episode of severe low blood sugar that require emergency treatment, hospitalization or third parties to administer rescue treatment, in the past 6 months
Have any lifetime history of a suicide attempt
Have other medical conditions or medical history that make participation in the study unsafe or which may interfere in the interpretation of the results of the study
Unwilling to comply with smoking and alcohol restrictions during the study

Trial locations and contacts

1 site in 1 country.

United States1 site

Clinical Pharmacology of Miami
Hialeah, Florida, 33014

Other trials in United States

About this study

Official title: The Impact of Tirzepatide on Gastric Emptying (GE) in Overweight/Obese Non-diabetic Subjects and in Overweight/Obese Subjects With Type 2 Diabetes Mellitus

The study will last about 13 weeks for each participant, including screening.

Conditions: Overweight, Obesity, Diabetes Mellitus, Type 2
Being tested: Tirzepatide, Acetaminophen
Medical subject headings: Overweight, Obesity, Diabetes Mellitus, Type 2

What participants receive

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

TirzepatideDrug
Also called LY3298176
Tirzepatide administered SC.
AcetaminophenDrug
Acetaminophen administered orally.

Study groups in NCT04407234
Study group	Role	What they receive
Tirzepatide + Acetaminophen	Experimental	Participants received 5mg tirzepatide on Day 1 and Day 8; 10 mg tirzepatide on Day 15, 22 and 29; 15 mg tirzepatide on Day 36 administered subcutaneously (SC) and 160 mg acetaminophen administered orally on Day -1, Day 2 and Day 37. Receives: Drug: Tirzepatide; Drug: Acetaminophen

What is being measured

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

Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration [ AUC(0-tlast)] of Acetaminophen
Area Under the Concentration Time Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration [ AUC(0-tlast)] of Acetaminophen
Measured: Pre-dose, 0.5, 0.75, 1, 2, 3, 4, 6, 9, 12, 24 and 36 hours post-dose on Day 1, Day 2 and Day 37 , Day 2 and Day 37
PK: Maximum Observed Drug Concentration (Cmax) of Acetaminophen
Maximum Observed Drug Concentration (cmax) of Acetaminophen
Measured: Pre-dose, 0.5, 0.75, 1, 2, 3, 4, 6, 9, 12, 24 and 36 hours post-dose on Day 1, Day 2 and Day 37 , Day 2 and Day 37

Secondary outcomes (5)

Hemoglobin A1c (HbA1c) Data by Diabetic Status
Levels of Hemoglobin A1c (HbA1c) were assessed at predose on Day 29, and at follow-up (Day 64).
Measured: Predose on Day 29 and follow-up (Day 64)
PK: Area Under the Concentration Time Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration [ AUC(0-tlast)] of Acetaminophen at Steady State For Non-diabetic
Area Under the Concentration Time Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration [ AUC(0-tlast)] of Acetaminophen at Steady State For Non-diabetic
Measured: Pre-dose, 0.5, 0.75, 1, 2, 3, 4, 6, 9, 12, 24 and 36 hours post-dose on Day 1, Day 2 and Day 37 , Day 2 and Day 37
PK: Area Under the Concentration Versus Time Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration [ AUC(0-tlast)] of Acetaminophen at Steady State For T2DM
Area Under the Concentration Versus Time Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration [ AUC(0-tlast)] of Acetaminophen at Steady State For T2DM
Measured: Pre-dose, 0.5, 0.75, 1, 2, 3, 4, 6, 9, 12, 24 and 36 hours post-dose on Day 1, Day 2 and Day 37 , Day 2 and Day 37
PK: Cmax of Acetaminophen at Steady State Non-diabetic
PK: Cmax of Acetaminophen at Steady State Non-diabetic
Measured: Pre-dose, 0.5, 0.75, 1, 2, 3, 4, 6, 9, 12, 24 and 36 hours post-dose on Day 1, Day 2 and Day 37 , Day 2 and Day 37
PK: Cmax of Acetaminophen at Steady State For T2DM
PK: Cmax of Acetaminophen at Steady State T2DM
Measured: Pre-dose, 0.5, 0.75, 1, 2, 3, 4, 6, 9, 12, 24 and 36 hours post-dose on Day 1, Day 2 and Day 37 , Day 2 and Day 37

Timeline

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

15 Sep 20207 Jan 2021

First posted29 May 2020
Study start15 Sep 2020
Primary completion7 Jan 2021
Study completion7 Jan 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 OverweightStudies 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04407234
Sponsor's protocol ID: 17376
Other IDs: I8F-MC-GPHU
Status last verified: Apr 2023
First submitted: 27 May 2020
Last updated: 8 Jan 2024
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 8 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Impact of Tirzepatide on Gastric Emptying (GE) in Overweight/Obese Non-diabetic Subjects and in Overweight/Obese Subjects With Type 2 Diabetes Mellitus
ClinicalTrials.gov ID: NCT04407234
Acronym / sponsor ID: 17376
Conditions: Overweight, Obesity, Diabetes Mellitus, Type 2
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: 15 Sep 2020 (actual)
Primary completion: 7 Jan 2021 (actual)
Study completion: 7 Jan 2021 (actual)
First posted: 29 May 2020 (actual)
Results: Posted 8 Jan 2024

Clinical summary

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

The study will last about 13 weeks for each participant, including screening.

Study design

Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Tirzepatide + Acetaminophen	Experimental	Drug: Tirzepatide, Drug: AcetaminophenParticipants received 5mg tirzepatide on Day 1 and Day 8; 10 mg tirzepatide on Day 15, 22 and 29; 15 mg tirzepatide on Day 36 administered subcutaneously (SC) and 160 mg acetaminophen administered orally on Day -1, Day 2 and Day 37.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Have a body mass index (BMI) between 27 to 45 kilograms per meter squared (kg/m²), inclusive at screening
For nondiabetic subjects: as determined by medical history, physical examination, and safety assessments at screening
For participants with a confirmed type 2 diabetes diagnosis: The condition must be managed either by diet and exercise alone or on a stable dose of metformin for the past 3 months
Willing and agreeable to commit to the duration of the study and undergo study procedures as instructed by the clinic staff

Key exclusion criteria (6 listed)

Have undergone gastric bypass or bariatric surgery
Have received prescription drugs or over the counter drugs that promote weight loss in the past 6 months prior to screening
For participants with a confirmed type 2 diabetes diagnosis: Have experienced more than 1 episode of severe low blood sugar that require emergency treatment, hospitalization or third parties to administer rescue treatment, in the past 6 months
Have any lifetime history of a suicide attempt
Have other medical conditions or medical history that make participation in the study unsafe or which may interfere in the interpretation of the results of 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: LY3298176Tirzepatide administered SC.	Drug	Tirzepatide + Acetaminophen
AcetaminophenAcetaminophen administered orally.	Drug	Tirzepatide + Acetaminophen

Primary outcome

Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration [ AUC(0-tlast)] of Acetaminophen
Time frame: Pre-dose, 0.5, 0.75, 1, 2, 3, 4, 6, 9, 12, 24 and 36 hours post-dose on Day 1, Day 2 and Day 37 , Day 2 and Day 37
Area Under the Concentration Time Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration [ AUC(0-tlast)] of Acetaminophen
PK: Maximum Observed Drug Concentration (Cmax) of Acetaminophen
Time frame: Pre-dose, 0.5, 0.75, 1, 2, 3, 4, 6, 9, 12, 24 and 36 hours post-dose on Day 1, Day 2 and Day 37 , Day 2 and Day 37
Maximum Observed Drug Concentration (cmax) of Acetaminophen

5 secondary outcomes

Hemoglobin A1c (HbA1c) Data by Diabetic Status
Time frame: Predose on Day 29 and follow-up (Day 64)
PK: Area Under the Concentration Time Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration [ AUC(0-tlast)] of Acetaminophen at Steady State For Non-diabetic
Time frame: Pre-dose, 0.5, 0.75, 1, 2, 3, 4, 6, 9, 12, 24 and 36 hours post-dose on Day 1, Day 2 and Day 37 , Day 2 and Day 37
PK: Area Under the Concentration Versus Time Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration [ AUC(0-tlast)] of Acetaminophen at Steady State For T2DM
Time frame: Pre-dose, 0.5, 0.75, 1, 2, 3, 4, 6, 9, 12, 24 and 36 hours post-dose on Day 1, Day 2 and Day 37 , Day 2 and Day 37
PK: Cmax of Acetaminophen at Steady State Non-diabetic
Time frame: Pre-dose, 0.5, 0.75, 1, 2, 3, 4, 6, 9, 12, 24 and 36 hours post-dose on Day 1, Day 2 and Day 37 , Day 2 and Day 37
PK: Cmax of Acetaminophen at Steady State For T2DM
Time frame: Pre-dose, 0.5, 0.75, 1, 2, 3, 4, 6, 9, 12, 24 and 36 hours post-dose on Day 1, Day 2 and Day 37 , Day 2 and Day 37

Results and safety

Results posted to the registry on 8 Jan 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Non-Diabetic	18	15
Type 2 Diabetes Mellitus (T2DM)	18	15

Primary outcome: Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration [ AUC(0-tlast)] of Acetaminophen

Time frame: Pre-dose, 0.5, 0.75, 1, 2, 3, 4, 6, 9, 12, 24 and 36 hours post-dose on Day 1, Day 2 and Day 37 , Day 2 and Day 37. Geometric mean (90% Confidence Interval). Unit: nanograms*hours per milliliter (ng*h/mL)

Measure	Reference:160 mg Acetaminophen (Day -1) n = 36	Test: 5 mg Tirzepatide + 160 mg Acetaminophen (Day 2) n = 36	Test: 15 mg Tirzepatide + 160 mg Acetaminophen (Day 37) n = 30
Value	49384 (43635 to 55890)	43523 (38456 to 49257)	57049 (50171 to 64869)

Reference:160 mg Acetaminophen (Day -1) vs Test: 5 mg Tirzepatide + 160 mg Acetaminophen (Day 2): Ratio of geometric least squares mean: 0.881 (90% CI 0.803 to 0.967), Wilcoxon signed rank test
Reference:160 mg Acetaminophen (Day -1) vs Test: 15 mg Tirzepatide + 160 mg Acetaminophen (Day 37): Ratio of geometric least squares mean: 1.16 (90% CI 1.05 to 1.28), Wilcoxon signed rank test

Population analysed: All randomized participants who received at least one dose of acetaminophen and have evaluable acetaminophen PK data.

Primary outcome: PK: Maximum Observed Drug Concentration (Cmax) of Acetaminophen

Time frame: Pre-dose, 0.5, 0.75, 1, 2, 3, 4, 6, 9, 12, 24 and 36 hours post-dose on Day 1, Day 2 and Day 37 , Day 2 and Day 37. Geometric mean (90% Confidence Interval). Unit: nanograms per milliliter (ng/mL)

Measure	Reference:160 mg Acetaminophen (Day -1) n = 36	Test: 5 mg Tirzepatide + 160 mg Acetaminophen (Day 2) n = 36	Test: 15 mg Tirzepatide + 160 mg Acetaminophen (Day 37 n = 30
Value	11925 (10566 to 13460)	5314 (4708 to 5998)	8099 (7111 to 9225)

Reference:160 mg Acetaminophen (Day -1) vs Test: 5 mg Tirzepatide + 160 mg Acetaminophen (Day 2): Ratio of geometric least squares mean: 0.446 (90% CI 0.390 to 0.509), Wilcoxon signed rank test
Reference:160 mg Acetaminophen (Day -1) vs Test: 15 mg Tirzepatide + 160 mg Acetaminophen (Day 37: Ratio of geometric least squares mean: 0.679 (90% CI 0.589 to 0.783), Wilcoxon signed rank test

Population analysed: All randomized participants who received at least one dose of acetaminophen and have evaluable acetaminophen PK data.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline Up To 45 Days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Non-diabetic	0 of 18 (0%)	16 of 18 (88.9%)	0 of 18
T2DM	0 of 18 (0%)	16 of 18 (88.9%)	0 of 18

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.
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 Acetaminophen in people with Overweight and Obesity, 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 4 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 8 Jan 2024. 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 8 Jan 2024). 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?

Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration [ AUC(0-tlast)] of Acetaminophen (time frame: Pre-dose, 0.5, 0.75, 1, 2, 3, 4, 6, 9, 12, 24 and 36 hours post-dose on Day 1, Day 2 and Day 37 , Day 2 and Day 37). The study lists 2 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 NCT04407234.

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 8 Jan 2024.