Trial Outcomes & Findings for A Study to Measure Stomach Emptying in Overweight Non-diabetic and Diabetic Participants Using Tirzepatide (NCT NCT04407234)

Last Updated: 2024-01-08

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

36 participants

Primary outcome timeframe

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 posted on

2024-01-08

Participant Flow

Participant milestones

Participant milestones
Measure	Non-Diabetic Participants received 5 milligrams (mg) 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.	Type 2 Diabetes Mellitus (T2DM) 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 SC and 160 mg acetaminophen administered orally on Day -1, Day 2 and Day 37.
Overall Study STARTED	18	18
Overall Study Received at Least One Dose of Study Drug	18	18
Overall Study COMPLETED	15	15
Overall Study NOT COMPLETED	3	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Non-Diabetic Participants received 5 milligrams (mg) 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.	Type 2 Diabetes Mellitus (T2DM) 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 SC and 160 mg acetaminophen administered orally on Day -1, Day 2 and Day 37.
Overall Study Adverse Event	3	3

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Non-Diabetic n=18 Participants Participants 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.	T2DM n=18 Participants Participants 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.	Total n=36 Participants Total of all reporting groups
Age, Continuous	43.9 years STANDARD_DEVIATION 10.8 • n=5 Participants	56.2 years STANDARD_DEVIATION 5.5 • n=7 Participants	50.1 years STANDARD_DEVIATION 10.5 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	13 Participants n=7 Participants	23 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	5 Participants n=7 Participants	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	18 Participants n=5 Participants	18 Participants n=7 Participants	36 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants	16 Participants n=7 Participants	30 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	18 Participants n=5 Participants	18 Participants n=7 Participants	36 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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

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

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

Outcome measures

Outcome measures
Measure	Reference:160 mg Acetaminophen (Day -1) n=36 Participants Participants received 160 mg acetaminophen administered orally on Day -1.	Test: 5 mg Tirzepatide + 160 mg Acetaminophen (Day 2) n=36 Participants Participants received 5 mg tirzepatide on Day 1 and Day 8 and 160 mg acetaminophen administered orally Day 2.	Test: 15 mg Tirzepatide + 160 mg Acetaminophen (Day 37) n=30 Participants Participants received 15 mg tirzepatide on Day 36 administered SC and 160 mg acetaminophen administered orally on 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	49384 nanogramshours per milliliter (ngh/mL) Interval 43635.0 to 55890.0	43523 nanogramshours per milliliter (ngh/mL) Interval 38456.0 to 49257.0	57049 nanogramshours per milliliter (ngh/mL) Interval 50171.0 to 64869.0

PRIMARY outcome

Timeframe: 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

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

Maximum Observed Drug Concentration (cmax) of Acetaminophen

Outcome measures

Outcome measures
Measure	Reference:160 mg Acetaminophen (Day -1) n=36 Participants Participants received 160 mg acetaminophen administered orally on Day -1.	Test: 5 mg Tirzepatide + 160 mg Acetaminophen (Day 2) n=36 Participants Participants received 5 mg tirzepatide on Day 1 and Day 8 and 160 mg acetaminophen administered orally Day 2.	Test: 15 mg Tirzepatide + 160 mg Acetaminophen (Day 37) n=30 Participants Participants received 15 mg tirzepatide on Day 36 administered SC and 160 mg acetaminophen administered orally on Day 37.
PK: Maximum Observed Drug Concentration (Cmax) of Acetaminophen	11925 nanograms per milliliter (ng/mL) Interval 10566.0 to 13460.0	5314 nanograms per milliliter (ng/mL) Interval 4708.0 to 5998.0	8099 nanograms per milliliter (ng/mL) Interval 7111.0 to 9225.0

SECONDARY outcome

Timeframe: Predose on Day 29 and follow-up (Day 64)

Population: All participants who received at least one dose of acetaminophen or tirzepatide, whether or not they completed all protocol requirements

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

Outcome measures

Outcome measures
Measure	Reference:160 mg Acetaminophen (Day -1) n=15 Participants Participants received 160 mg acetaminophen administered orally on Day -1.	Test: 5 mg Tirzepatide + 160 mg Acetaminophen (Day 2) n=15 Participants Participants received 5 mg tirzepatide on Day 1 and Day 8 and 160 mg acetaminophen administered orally Day 2.	Test: 15 mg Tirzepatide + 160 mg Acetaminophen (Day 37) Participants received 15 mg tirzepatide on Day 36 administered SC and 160 mg acetaminophen administered orally on Day 37.
Hemoglobin A1c (HbA1c) Data by Diabetic Status Day 29 ± 1	5.37 Percentage of HbA1c Standard Deviation 0.45	7.27 Percentage of HbA1c Standard Deviation 0.79	—
Hemoglobin A1c (HbA1c) Data by Diabetic Status Day 64 ± 1 (Follow-Up)	5.29 Percentage of HbA1c Standard Deviation 0.45	6.87 Percentage of HbA1c Standard Deviation 0.75	—

SECONDARY outcome

Timeframe: 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

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

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

Outcome measures

Outcome measures
Measure	Reference:160 mg Acetaminophen (Day -1) n=18 Participants Participants received 160 mg acetaminophen administered orally on Day -1.	Test: 5 mg Tirzepatide + 160 mg Acetaminophen (Day 2) n=18 Participants Participants received 5 mg tirzepatide on Day 1 and Day 8 and 160 mg acetaminophen administered orally Day 2.	Test: 15 mg Tirzepatide + 160 mg Acetaminophen (Day 37) n=15 Participants Participants received 15 mg tirzepatide on Day 36 administered SC and 160 mg acetaminophen administered orally on 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	44350 nanogramshours per milliliter (ngh/mL) Interval 37276.0 to 52766.0	39389 nanogramshours per milliliter (ngh/mL) Interval 33107.0 to 46864.0	54735 nanogramshours per milliliter (ngh/mL) Interval 45695.0 to 65563.0

SECONDARY outcome

Timeframe: 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

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

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

Outcome measures

Outcome measures
Measure	Reference:160 mg Acetaminophen (Day -1) n=18 Participants Participants received 160 mg acetaminophen administered orally on Day -1.	Test: 5 mg Tirzepatide + 160 mg Acetaminophen (Day 2) n=18 Participants Participants received 5 mg tirzepatide on Day 1 and Day 8 and 160 mg acetaminophen administered orally Day 2.	Test: 15 mg Tirzepatide + 160 mg Acetaminophen (Day 37) n=15 Participants Participants received 15 mg tirzepatide on Day 36 administered SC and 160 mg acetaminophen administered orally on 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	54989 nanogramshours per milliliter (ngh/mL) Interval 46219.0 to 65424.0	48090 nanogramshours per milliliter (ngh/mL) Interval 40420.0 to 57215.0	59440 nanogramshours per milliliter (ngh/mL) Interval 49623.0 to 71199.0

SECONDARY outcome

Timeframe: 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

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

PK: Cmax of Acetaminophen at Steady State Non-diabetic

Outcome measures

Outcome measures
Measure	Reference:160 mg Acetaminophen (Day -1) n=18 Participants Participants received 160 mg acetaminophen administered orally on Day -1.	Test: 5 mg Tirzepatide + 160 mg Acetaminophen (Day 2) n=18 Participants Participants received 5 mg tirzepatide on Day 1 and Day 8 and 160 mg acetaminophen administered orally Day 2.	Test: 15 mg Tirzepatide + 160 mg Acetaminophen (Day 37) n=15 Participants Participants received 15 mg tirzepatide on Day 36 administered SC and 160 mg acetaminophen administered orally on Day 37.
PK: Cmax of Acetaminophen at Steady State Non-diabetic	10255 nanograms per milliliter (ng/mL) Interval 8680.0 to 12115.0	4646 nanograms per milliliter (ng/mL) Interval 3932.0 to 5489.0	8245 nanograms per milliliter (ng/mL) Interval 6891.0 to 9866.0

SECONDARY outcome

Timeframe: 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

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

PK: Cmax of Acetaminophen at Steady State T2DM

Outcome measures

Outcome measures
Measure	Reference:160 mg Acetaminophen (Day -1) n=18 Participants Participants received 160 mg acetaminophen administered orally on Day -1.	Test: 5 mg Tirzepatide + 160 mg Acetaminophen (Day 2) n=18 Participants Participants received 5 mg tirzepatide on Day 1 and Day 8 and 160 mg acetaminophen administered orally Day 2.	Test: 15 mg Tirzepatide + 160 mg Acetaminophen (Day 37) n=15 Participants Participants received 15 mg tirzepatide on Day 36 administered SC and 160 mg acetaminophen administered orally on Day 37.
PK: Cmax of Acetaminophen at Steady State For T2DM	13868 nanograms per milliliter (ng/mL) Interval 11738.0 to 16385.0	6078 nanograms per milliliter (ng/mL) Interval 5144.0 to 7181.0	7954 nanograms per milliliter (ng/mL) Interval 6648.0 to 9517.0

Adverse Events

Non-diabetic

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

T2DM

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60

Measure	Non-diabetic n=18 participants at risk Participants 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.	T2DM n=18 participants at risk Participants 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.
Cardiac disorders Palpitations	5.6% 1/18 • Number of events 1 • Baseline Up To 45 Days All participants who received at least one dose of study drug.	0.00% 0/18 • Baseline Up To 45 Days All participants who received at least one dose of study drug.
Cardiac disorders Tachycardia	5.6% 1/18 • Number of events 1 • Baseline Up To 45 Days All participants who received at least one dose of study drug.	5.6% 1/18 • Number of events 1 • Baseline Up To 45 Days All participants who received at least one dose of study drug.
Gastrointestinal disorders Abdominal distension	33.3% 6/18 • Number of events 6 • Baseline Up To 45 Days All participants who received at least one dose of study drug.	44.4% 8/18 • Number of events 9 • Baseline Up To 45 Days All participants who received at least one dose of study drug.
Gastrointestinal disorders Abdominal pain	0.00% 0/18 • Baseline Up To 45 Days All participants who received at least one dose of study drug.	5.6% 1/18 • Number of events 1 • Baseline Up To 45 Days All participants who received at least one dose of study drug.
Gastrointestinal disorders Abdominal tenderness	0.00% 0/18 • Baseline Up To 45 Days All participants who received at least one dose of study drug.	5.6% 1/18 • Number of events 1 • Baseline Up To 45 Days All participants who received at least one dose of study drug.
Gastrointestinal disorders Constipation	22.2% 4/18 • Number of events 4 • Baseline Up To 45 Days All participants who received at least one dose of study drug.	11.1% 2/18 • Number of events 3 • Baseline Up To 45 Days All participants who received at least one dose of study drug.
Gastrointestinal disorders Diarrhoea	5.6% 1/18 • Number of events 1 • Baseline Up To 45 Days All participants who received at least one dose of study drug.	5.6% 1/18 • Number of events 2 • Baseline Up To 45 Days All participants who received at least one dose of study drug.
Gastrointestinal disorders Dyspepsia	5.6% 1/18 • Number of events 1 • Baseline Up To 45 Days All participants who received at least one dose of study drug.	22.2% 4/18 • Number of events 4 • Baseline Up To 45 Days All participants who received at least one dose of study drug.
Gastrointestinal disorders Flatulence	11.1% 2/18 • Number of events 2 • Baseline Up To 45 Days All participants who received at least one dose of study drug.	5.6% 1/18 • Number of events 1 • Baseline Up To 45 Days All participants who received at least one dose of study drug.
Gastrointestinal disorders Gastrooesophageal reflux disease	22.2% 4/18 • Number of events 4 • Baseline Up To 45 Days All participants who received at least one dose of study drug.	0.00% 0/18 • Baseline Up To 45 Days All participants who received at least one dose of study drug.
Gastrointestinal disorders Lip dry	0.00% 0/18 • Baseline Up To 45 Days All participants who received at least one dose of study drug.	5.6% 1/18 • Number of events 1 • Baseline Up To 45 Days All participants who received at least one dose of study drug.
Gastrointestinal disorders Nausea	38.9% 7/18 • Number of events 7 • Baseline Up To 45 Days All participants who received at least one dose of study drug.	77.8% 14/18 • Number of events 19 • Baseline Up To 45 Days All participants who received at least one dose of study drug.
Gastrointestinal disorders Vomiting	16.7% 3/18 • Number of events 4 • Baseline Up To 45 Days All participants who received at least one dose of study drug.	38.9% 7/18 • Number of events 16 • Baseline Up To 45 Days All participants who received at least one dose of study drug.
General disorders Chills	0.00% 0/18 • Baseline Up To 45 Days All participants who received at least one dose of study drug.	11.1% 2/18 • Number of events 2 • Baseline Up To 45 Days All participants who received at least one dose of study drug.
General disorders Fatigue	5.6% 1/18 • Number of events 1 • Baseline Up To 45 Days All participants who received at least one dose of study drug.	16.7% 3/18 • Number of events 3 • Baseline Up To 45 Days All participants who received at least one dose of study drug.
General disorders Pain	0.00% 0/18 • Baseline Up To 45 Days All participants who received at least one dose of study drug.	5.6% 1/18 • Number of events 1 • Baseline Up To 45 Days All participants who received at least one dose of study drug.
Metabolism and nutrition disorders Decreased appetite	88.9% 16/18 • Number of events 16 • Baseline Up To 45 Days All participants who received at least one dose of study drug.	22.2% 4/18 • Number of events 6 • Baseline Up To 45 Days All participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Back pain	5.6% 1/18 • Number of events 1 • Baseline Up To 45 Days All participants who received at least one dose of study drug.	22.2% 4/18 • Number of events 5 • Baseline Up To 45 Days All participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/18 • Baseline Up To 45 Days All participants who received at least one dose of study drug.	5.6% 1/18 • Number of events 2 • Baseline Up To 45 Days All participants who received at least one dose of study drug.
Nervous system disorders Dysgeusia	0.00% 0/18 • Baseline Up To 45 Days All participants who received at least one dose of study drug.	5.6% 1/18 • Number of events 1 • Baseline Up To 45 Days All participants who received at least one dose of study drug.
Nervous system disorders Headache	16.7% 3/18 • Number of events 3 • Baseline Up To 45 Days All participants who received at least one dose of study drug.	11.1% 2/18 • Number of events 3 • Baseline Up To 45 Days All participants who received at least one dose of study drug.
Nervous system disorders Hypoaesthesia	11.1% 2/18 • Number of events 2 • Baseline Up To 45 Days All participants who received at least one dose of study drug.	0.00% 0/18 • Baseline Up To 45 Days All participants who received at least one dose of study drug.
Nervous system disorders Paraesthesia	0.00% 0/18 • Baseline Up To 45 Days All participants who received at least one dose of study drug.	5.6% 1/18 • Number of events 1 • Baseline Up To 45 Days All participants who received at least one dose of study drug.