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Trial · Interventional

CompletedPhase 1Results postedRegistry data

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

NCTNCT04407234 (opens ClinicalTrials.gov in a new tab)Other id17376Other idI8F-MC-GPHU
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 1
Enrollment
36 participants (actual)
Sponsor
Eli Lilly and Company · Industry
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
15 Sept 2020
Primary completion
7 Jan 2021
Completion
7 Jan 2021
First posted
29 May 2020
Last update posted
8 Jan 2024
Conditions
Overweight · Obesity · Diabetes Mellitus, Type 2

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202020212022
  1. Ph 1

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

    NCT04407234

    15 Sept 2020 to 7 Jan 2021

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • TirzepatideDrug
  • AcetaminophenDrug

Arms1

  • Experimental

    Tirzepatide + Acetaminophen

    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.

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. 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

    Registry description

    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

  2. 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

    Registry description

    Maximum Observed Drug Concentration (cmax) of Acetaminophen

Secondary outcomes(5)

  1. Hemoglobin A1c (HbA1c) Data by Diabetic Status

    Time frame · Predose on Day 29 and follow-up (Day 64)

    Registry description

    Levels of Hemoglobin A1c (HbA1c) were assessed at predose on Day 29, and at follow-up (Day 64).

  2. 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

    Registry description

    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

  3. 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

    Registry description

    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

  4. 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

    Registry description

    PK: Cmax of Acetaminophen at Steady State Non-diabetic

  5. 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

    Registry description

    PK: Cmax of Acetaminophen at Steady State T2DM

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeGeometric mean· 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

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

GroupValue (nanograms*hours per milliliter (ng*h/mL))
Reference:160 mg Acetaminophen (Day -1)49384
Test: 5 mg Tirzepatide + 160 mg Acetaminophen (Day 2)43523
Test: 15 mg Tirzepatide + 160 mg Acetaminophen (Day 37)57049
Primary outcomeGeometric mean· 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

GroupValue (nanograms per milliliter (ng/mL))
Reference:160 mg Acetaminophen (Day -1)11925
Test: 5 mg Tirzepatide + 160 mg Acetaminophen (Day 2)5314
Test: 15 mg Tirzepatide + 160 mg Acetaminophen (Day 378099
Secondary and other outcome results(5)
Secondary outcomeMean· Predose on Day 29 and follow-up (Day 64)

Hemoglobin A1c (HbA1c) Data by Diabetic Status

GroupValue (Percentage of HbA1c)Spread
Non-Diabetic5.370.45
T2DM7.270.79
Secondary outcomeGeometric least squares mean· 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 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

GroupValue (nanograms*hours per milliliter (ng*h/mL))
Reference (Non-diabetic):160 mg Acetaminophen (Day -1)44350
Test (Non-diabetic): 5 mg Tirzepatide + 160 mg Acetaminophen (Day 2)39389
Test (Non-diabetic): 15 mg Tirzepatide + 160 mg Acetaminophen (Day 37)54735
Secondary outcomeGeometric least squares mean· 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

GroupValue (nanograms*hours per milliliter (ng*h/mL))
Reference (T2DM):160 mg Acetaminophen (Day -1)54989
Test (T2DM): 5 mg Tirzepatide + 160 mg Acetaminophen (Day 2)48090
Test (T2DM): 15 mg Tirzepatide + 160 mg Acetaminophen (Day 37)59440
Secondary outcomeGeometric least squares mean· 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

GroupValue (nanograms per milliliter (ng/mL))
Reference (Non-diabetic):160 mg Acetaminophen (Day -1)10255
Test (Non-diabetic): 5 mg Tirzepatide + 160 mg Acetaminophen (Day 2)4646
Test (Non-diabetic): 15 mg Tirzepatide + 160 mg Acetaminophen (Day 37)8245
Secondary outcomeGeometric least squares mean· 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

GroupValue (nanograms per milliliter (ng/mL))
Reference (T2DM):160 mg Acetaminophen (Day -1)13868
Test (T2DM): 5 mg Tirzepatide + 160 mg Acetaminophen (Day 2)6078
Test (T2DM): 15 mg Tirzepatide + 160 mg Acetaminophen (Day 37)7954

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Non-diabeticParticipants received 5 mg tirzepatide on Day 1 and Day 8; 10 mg tirzepatide on Day 15, 22 and 29; 15 mg tirzepatide on Day 36 administered SC and 160 mg acetaminophen administered orally on Day -1, Day 2 and Day 37.0 / 180 / 1816 / 18
T2DMParticipants received 5 mg tirzepatide on Day 1 and Day 8; 10 mg tirzepatide on Day 15, 22 and 29; 15 mg tirzepatide on Day 36 administered SC and 160 mg acetaminophen administered orally on Day -1, Day 2 and Day 37.0 / 180 / 1816 / 18

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 65 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 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 * 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

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