Trial · Interventional

CompletedPhase 2Results postedRegistry data

A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes

NCTNCT03311724Other id16860Other idI8F-MC-GPGF

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Overview

Status: Completed
Phase: Phase 2
Enrollment: 111 participants (actual)
Sponsor: Eli Lilly and Company · Industry
Design: Randomized · Double masking
Countries: 1 country
United States
Start: 19 Oct 2017
Primary completion: 24 Apr 2018
Completion: 24 Apr 2018
First posted: 17 Oct 2017
Last update posted: 19 May 2021
Conditions: Type 2 Diabetes

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

201720182019

Ph 2
A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes
NCT03311724
19 Oct 2017 to 24 Apr 2018

Registry summary

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

The purpose of this study is to determine the efficacy of tirzepatide in participants with type 2 diabetes.

Interventions

TirzepatideDrug
PlaceboDrug

Arms4

Experimental
4,8,12mg Tirzepatide
Participants received Tirzepatide by subcutaneous (SC) injection in three dose escalations starting with 4 milligrams (mg) for four weeks followed by 8mg for four weeks followed by 12mg for four weeks.
Experimental
2.5,5,10,15mg Tirzepatide
Participants received Tirzepatide by SC injection in four dose escalations starting with 2.5mg for two weeks followed by 5mg for two weeks followed by 10mg for four weeks followed by 15mg for four weeks.
Experimental
2.5,7.5,15mg Tirzepatide
Participants received Tirzepatide by SC injection in three dose escalations starting with 2.5mg for four weeks followed by 7.5mg for four weeks followed by 15mg for four weeks.
Placebo comparator
Placebo
Placebo administered by SC injection.

Primary outcomes1

Outcomes the sponsor listed as primary.

Change From Baseline in Haemoglobin A1c (HbA1c)
Time frame · Baseline, 3 Months
Registry description
Least squares (LS) mean was calculated using mixed model repeated measures model (MMRM) with baseline + baseline BMI group + baseline metformin flag + treatment + time + treatment\*time as fixed factors.

Secondary outcomes(7)

Percentage of Participants Achieving HbA1c Target of <7.0%
Time frame · 3 Months
Registry description
Percentage of participants achieving HbA1c target of \< (less than) 7.0%.
Change From Baseline in Fasting Blood Glucose (FBG)
Time frame · Baseline, 3 Months
Registry description
LSMean was calculated using MMRM model with baseline + baseline HbA1C group + baseline BMI group + baseline Metformin flag + treatment + time + treatment\*time as fixed factors.
Change From Baseline in Body Weight
Time frame · Baseline, 3 Months
Registry description
LSMean was calculated using MMRM model with baseline + baseline HbA1C group + baseline BMI group + baseline Metformin flag + treatment + time + treatment\*time as fixed factors.
Change From Baseline in Waist Circumference
Time frame · Baseline, 3 Months
Registry description
LSMean was calculated using MMRM model with baseline + baseline HbA1C group + baseline BMI group + baseline Metformin flag + treatment + time + treatment\*time as fixed factors.
Number of Participants With Anti Drug Antibodies
Time frame · Baseline through 3 Months
Registry description
Number of participants with anti drug antibodies.
Number of Episodes of Total Hypoglycemia Episodes
Time frame · Baseline through 3 Months
Registry description
Number of episodes of total hypoglycemia episodes with plasma glucose \<= ( less than or equal to) 54 mg/dL.
Pharmacokinetics (PK): Average Trough Concentration (Conctrough) of Tirzepatide
Time frame · Week 4, 8 12: Pre-dose
Registry description
Pharmacokinetics (PK): Average Trough Concentration (Conctrough) of Tirzepatide.

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 outcomeLeast squares mean· Baseline, 3 Months

Change From Baseline in Haemoglobin A1c (HbA1c)

Group	Value (Percentage of HbA1C)	Spread
Placebo	0.2	0.21
4, 8 and 12mg Tirzepatide	-1.7	0.19
2.5, 5, 10, and 15mg Tirzepatide	-2.0	0.20
2.5, 7.5 and 15mg Tirzepatide	-1.8	0.19

Secondary and other outcome results(7)

Secondary outcomeNumber· 3 Months

Percentage of Participants Achieving HbA1c Target of <7.0%

Group	Value (percentage of participants)
Placebo	10
4, 8 and 12mg Tirzepatide	74.1
2.5, 5, 10, and 15mg Tirzepatide	87
2.5, 7.5 and 15mg Tirzepatide	84.6

Secondary outcomeLeast squares mean· Baseline, 3 Months

Change From Baseline in Fasting Blood Glucose (FBG)

Group	Value (milligrams per deciliter (mg/dL))	Spread
Placebo	-12.3	9.27
4, 8 and 12mg Tirzepatide	-60.7	8.21
2.5, 5, 10, and 15mg Tirzepatide	-70.2	8.72
2.5, 7.5 and 15mg Tirzepatide	-74.2	8.67

Secondary outcomeLeast squares mean· Baseline, 3 Months

Change From Baseline in Body Weight

Group	Value (kilogram (kg))	Spread
Placebo	-0.5	0.86
4, 8 and 12mg Tirzepatide	-5.3	0.78
2.5, 5, 10, and 15mg Tirzepatide	-5.5	0.80
2.5, 7.5 and 15mg Tirzepatide	-5.7	0.79

Secondary outcomeLeast squares mean· Baseline, 3 Months

Change From Baseline in Waist Circumference

Group	Value (centimeter (cm))	Spread
Placebo	-2.5	1.01
4, 8 and 12mg Tirzepatide	-4.8	0.90
2.5, 5, 10, and 15mg Tirzepatide	-4.9	0.94
2.5, 7.5 and 15mg Tirzepatide	-4.9	0.93

Secondary outcomeNumber· Baseline through 3 Months

Number of Participants With Anti Drug Antibodies

Group	Value (participants)
Placebo	0
4, 8 and 12mg Tirzepatide	10
2.5, 5, 10, and 15mg Tirzepatide	8
2.5, 7.5 and 15mg Tirzepatide	4

Secondary outcomeNumber· Baseline through 3 Months

Number of Episodes of Total Hypoglycemia Episodes

Group	Value (Episodes)
Placebo	0
4, 8 and 12mg Tirzepatide	0
2.5, 5, 10, and 15mg Tirzepatide	0
2.5, 7.5 and 15mg Tirzepatide	1

Secondary outcomeMean· Week 4, 8 12: Pre-dose

Pharmacokinetics (PK): Average Trough Concentration (Conctrough) of Tirzepatide

Group	Value (nanograms per milliliter (ng/mL))	Spread
4, 8 and 12mg Tirzepatide	508	366
2.5, 5, 10, and 15mg Tirzepatide	704	518
2.5, 7.5 and 15mg Tirzepatide	630	414

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
PlaceboPlacebo administered SC	0 / 26	0 / 26	7 / 26
4, 8 and 12mg TirzepatideParticipants received Tirzepatide by SC injection in three dose escalations starting with 4mg for four weeks followed by 8mg for four weeks followed by 12mg for four weeks.	0 / 29	1 / 29	19 / 29
2.5, 5, 10, and 15mg TirzepatideParticipants received Tirzepatide by SC injection in four dose escalations starting with 2.5mg for two weeks followed by 5mg for two weeks followed by 10mg for four weeks followed by 15mg for four weeks.	0 / 28	0 / 28	18 / 28
2.5, 7.5 and 15mg TirzepatideParticipants received Tirzepatide by SC injection in three dose escalations starting with 2.5mg for four weeks followed by 7.5mg for four weeks followed by 15mg for four weeks.	0 / 28	0 / 28	22 / 28

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 75 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Have type 2 diabetes (T2DM) for ≥6 months according to the Criteria for Diagnosing Type 2 Diabetes Mellitus (American Diabetes Association 2017). * Have HbA1c of 7.0% to 10.5%, inclusive, as assessed by the central laboratory. * If on metformin, have been treated with stable doses of metformin for at least 3 months. * Have a body mass index (BMI) between 23 and 45 (Inclusive) kilograms per square meter. Exclusion Criteria: * Have type 1 diabetes (T1D). * Have used any glucose-lowering medication other than metformin within 3 months prior to study entry or during screening/lead-in period or have used any glucagon-like peptide-1 receptor agonists (GLP-1 RAs) at any time in the past 12 months. * Have had any of the following cardiovascular conditions: acute myocardial infarction (MI), New York Heart Association Class III or Class IV heart failure, or cerebrovascular accident (stroke). * Have acute or chronic hepatitis, signs and symptoms of any other liver disease other than nonalcoholic fatty liver disease (NAFLD), or alanine aminotransferase (ALT) level \>2.5 times the upper limit of the reference range, as determined by the central laboratory at study entry; participants with NAFLD are eligible for participation in this trial. * Have had chronic or acute pancreatitis any time prior to study entry. * Have an estimated glomerular filtration rate (eGFR) \<45 milliliters/minute/1.73 square meter, calculated by the Chronic Kidney Disease-Epidemiology (CKD-EPI) equation. * Have serum calcitonin ≥20 picograms per milliliter, as determined by the central laboratory at study entry. * Have any condition that is a contraindication for use of the GLP-1 RA class (per country-specific labels) at study entry or develop such condition between study entry and randomization.

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