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Trial · Interventional

CompletedPhase 2Results postedRegistry data

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

NCTNCT03131687 (opens ClinicalTrials.gov in a new tab)Other id16335Other idI8F-MC-GPGBOther id2016-004179-33Other id2016
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
318 participants (actual)
Sponsor
Eli Lilly and Company · Industry
Design
Randomized · Double masking
Countries
4 countries

United States, Poland, Puerto Rico, Slovakia

Start
24 May 2017
Primary completion
1 Aug 2018
Completion
1 Aug 2018
First posted
27 Apr 2017
Last update posted
20 Aug 2019
Conditions
Type 2 Diabetes Mellitus

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201720182019
  1. Ph 2

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

    NCT03131687

    24 May 2017 to 1 Aug 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 evaluate the efficacy of the study drug tirzepatide in participants with type 2 diabetes mellitus.

Interventions

  • tirzepatideDrug
  • DulaglutideDrug
  • PlaceboDrug

Arms6

  • Placebo comparator

    Placebo

    Tirzepatide placebo and dulaglutide placebo administered subcutaneously (SC) once weekly.

  • Experimental

    1 mg Tirzepatide

    1 milligrams (mg) tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.

  • Experimental

    5 mg Tirzepatide

    5 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.

  • Experimental

    10 mg Tirzepatide

    10 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.

  • Experimental

    15 mg Tirzepatide

    15 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.

  • Active comparator

    1.5 mg Dulaglutide

    1.5 mg Dulaglutide administered SC once weekly. Tirzepatide placebo administered SC once weekly.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change From Baseline to Week 26 in Hemoglobin A1c (HbA1c) Bayesian Dose Response

    Time frame · Baseline, Week 26

    Registry description

    HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.This was a Bayesian dose response analysis of HbA1c (%) change from baseline. At baseline: Mean (SD = Standard Deviation) of baseline HbA1c (%). After baseline: Posterior Mean (SD = Posterior Standard Deviation) of HbA1c (%) change from baseline. The Least Squares Mean is Posterior mean.

Secondary outcomes(16)

  1. Change From Baseline to Week 12 in Hemoglobin A1c (HbA1c) Bayesian Dose Response

    Time frame · Baseline, Week 12

    Registry description

    HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. This was a Bayesian dose response analysis of HbA1c (%) change from baseline. At baseline: Mean (SD = Standard Deviation) of baseline HbA1c (%). After baseline: Posterior Mean (SD = Posterior Standard Deviation) of HbA1c (%) change from baseline. The Least Squares Mean is Posterior mean.

  2. Change From Baseline to Week 26 in HbA1c

    Time frame · Baseline, Week 26

    Registry description

    HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. The Least Squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included the independent variables: Baseline + Baseline BMI Group + Baseline Metformin Flag + Treatment + Time + Treatment\*Time.

  3. Change From Baseline to Week 12 in HbA1c

    Time frame · Baseline, Week 12

    Registry description

    HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. The Least Squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included the independent variables: Baseline + Baseline BMI Group + Baseline Metformin Flag + Treatment + Time + Treatment\*Time.

  4. Change From Baseline in Body Weight

    Time frame · Baseline, Week 26

    Registry description

    Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with independent variables: Baseline + Baseline HbA1C Group + Baseline BMI Group + Baseline Metformin Flag + Treatment + Time + Treatment\*Time.

  5. Percentage of Participants With 5% or Greater Body Weight Loss From Baseline

    Time frame · Week 26

    Registry description

    Percentage of participants with 5% or greater body weight loss from baseline last observation carried forward (LOCF) analyses using Logistic regression model with Baseline value + Baseline HbA1C Group + Baseline BMI Group + Baseline Metformin + Treatment as factors.

  6. Percentage of Participants With 10% or Greater Body Weight Loss From Baseline

    Time frame · Week 26

    Registry description

    Percentage of participants with 10% or greater body weight loss from baseline LOCF analyses using Logistic regression model with Baseline value + Baseline HbA1C Group + Baseline BMI Group + Baseline Metformin + Treatment as factors.

  7. Percentage of Participants Reaching the HbA1c Target of ≤6.5%

    Time frame · Week 26

    Registry description

    Percentage of participants with HbA1c ≤6.5% at Week 26 using a logistic regression model for endpoint used last observation carried forward (LOCF) method including baseline value, baseline BMI Group, baseline Metformin and treatment as factors.

  8. Percentage of Participants Reaching the HbA1c Target of <7.0%

    Time frame · Week 26

    Registry description

    Percentage of participants with HbA1c \<7.0% at Week 26 using a logistic regression model for endpoint used last observation carried forward (LOCF) method including baseline value, baseline BMI Group, baseline Metformin and treatment as factors.

  9. Change From Baseline in Fasting Blood Glucose

    Time frame · Baseline, Week 26

    Registry description

    Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with covariates: Baseline + Baseline HbA1C Group + Baseline BMI Group + Baseline Metformin Flag + Treatment + Time + Treatment\*Time.

  10. Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C)

    Time frame · Baseline, Week 26

    Registry description

    LS means were calculated using MMRM model with independent variables: Baseline, Baseline HbA1C Group, Baseline BMI Group, Baseline Metformin Flag,Treatment, time, treatment\*time.

  11. Change From Baseline in Total Cholesterol

    Time frame · Baseline, Week 26

    Registry description

    LS means were calculated using MMRM model with independent variables: Baseline, Baseline HbA1C Group, Baseline BMI Group, Baseline Metformin Flag, Treatment, Time, Treatment\*Time.

  12. Change From Baseline in Triglycerides

    Time frame · Baseline, Week 26

    Registry description

    LS means were calculated using MMRM model with independent variables: Baseline, Baseline HbA1C Group, Baseline BMI Group, Baseline Metformin Flag, Treatment, Time, Treatment\*Time.

  13. Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C)

    Time frame · Baseline, Week 26

    Registry description

    LS means were calculated using MMRM model with independent variables: Baseline, Baseline HbA1C Group, Baseline BMI Group, Baseline Metformin Flag, Treatment, Time, Treatment\*Time.

  14. Change From Baseline in Waist Circumference

    Time frame · Baseline, Week 26

    Registry description

    LS means were calculated using MMRM model with independent variables: Baseline, Baseline HbA1C Group, Baseline BMI Group, Baseline Metformin Flag, Treatment, Time, Treatment\*Time.

  15. Number of Participants With Anti-Drug Antibodies

    Time frame · Baseline through Week 30

    Registry description

    Number of Participants With Anti-Drug Antibodies.

  16. Pharmacokinetics (PK): Model Predicted Concentration at Steady State (Css) of Tirzepatide

    Time frame · Predose: Week 1,8,12 and 26; Postdose: Week 1,2,4 and 12

    Registry description

    Pharmacokinetics (PK): Model Predicted Concentration at Steady State (Css) 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, Week 26

Change From Baseline to Week 26 in Hemoglobin A1c (HbA1c) Bayesian Dose Response

GroupValue (Percentage of HbA1c)Spread
Placebo-0.060.14
1 mg Tirzepatide-1.060.11
5 mg Tirzepatide-1.730.08
10 mg Tirzepatide-1.890.08
15 mg Tirzepatide-1.940.09
1.5 mg Dulaglutide-1.210.14
Secondary and other outcome results(7)
Secondary outcomeLeast squares mean· Baseline, Week 12

Change From Baseline to Week 12 in Hemoglobin A1c (HbA1c) Bayesian Dose Response

GroupValue (Percentage of HbA1c)Spread
Placebo-0.050.13
1 mg Tirzepatide-0.940.10
5 mg Tirzepatide-1.540.07
10 mg Tirzepatide-1.680.08
15 mg Tirzepatide-1.720.08
1.5 mg Dulaglutide-1.080.13
Secondary outcomeLeast squares mean· Baseline, Week 26

Change From Baseline to Week 26 in HbA1c

GroupValue (Percentage of HbA1c)Spread
Placebo0.10.16
1 mg Tirzepatide-0.70.16
5 mg Tirzepatide-1.60.15
10 mg Tirzepatide-2.00.16
15 mg Tirzepatide-2.40.17
1.5 mg Dulaglutide-1.10.15
Secondary outcomeLeast squares mean· Baseline, Week 12

Change From Baseline to Week 12 in HbA1c

GroupValue (Percentage of HbA1c)Spread
Placebo-0.10.13
1 mg Tirzepatide-0.90.13
5 mg Tirzepatide-1.70.13
10 mg Tirzepatide-2.00.13
15 mg Tirzepatide-2.10.15
1.5 mg Dulaglutide-1.20.13
Secondary outcomeLeast squares mean· Baseline, Week 26

Change From Baseline in Body Weight

GroupValue (Kilograms (Kg))Spread
Placebo-0.40.81
1 mg Tirzepatide-0.90.80
5 mg Tirzepatide-4.80.77
10 mg Tirzepatide-8.70.80
15 mg Tirzepatide-11.30.88
1.5 mg Dulaglutide-2.70.78
Secondary outcomeNumber· Week 26

Percentage of Participants With 5% or Greater Body Weight Loss From Baseline

GroupValue (percentage of participants)
Placebo0
1 mg Tirzepatide13.5
5 mg Tirzepatide47.3
10 mg Tirzepatide70.6
15 mg Tirzepatide62.3
1.5 mg Dulaglutide22.2
Secondary outcomeNumber· Week 26

Percentage of Participants With 10% or Greater Body Weight Loss From Baseline

GroupValue (percentage of participants)
Placebo0
1 mg Tirzepatide5.8
5 mg Tirzepatide16.4
10 mg Tirzepatide39.2
15 mg Tirzepatide37.7
1.5 mg Dulaglutide9.3
Secondary outcomeNumber· Week 26

Percentage of Participants Reaching the HbA1c Target of ≤6.5%

GroupValue (percentage of participants)
Placebo2.0
1 mg Tirzepatide15.4
5 mg Tirzepatide63.6
10 mg Tirzepatide82.0
15 mg Tirzepatide58.5
1.5 mg Dulaglutide38.9

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
PlaceboTirzepatide placebo and dulaglutide placebo administered (SC) once weekly.0 / 512 / 5117 / 51
1 mg Tirzepatide1 mg tirzepatide and placebo given SC once weekly.1 / 522 / 5217 / 52
5 mg Tirzepatide5 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.0 / 551 / 5529 / 55
10 mg Tirzepatide10 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.0 / 513 / 5132 / 51
15 mg Tirzepatide + Placebo15 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.0 / 532 / 5339 / 53
1.5 mg Dulaglutide1.5 mg Dulaglutide administered SC once weekly. Tirzepatide placebo administered SC once weekly.0 / 543 / 5431 / 54

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

Studies4

Studies that cite this trial.

Studies with results

4 studies on this page

Indexing hint: Randomized controlled trial · 2022

11 results

Effects of Tirzepatide, a Dual GIP and GLP-1 RA, on Lipid and Metabolite Profiles in Subjects With Type 2 Diabetes.

Pirro et al. 2022The Journal of clinical endocrinology and metabolismcited by 95

PMID 34608929DOI 10.1210/clinem/dgab722PUB-34608929

Rights unknown11 results
Source linkSee results (11)

Indexing hint: Meta-analysis (pooled) · 2022

4 results

Tirzepatide cardiovascular event risk assessment: a pre-specified meta-analysis.

Sattar et al. 2022Nature medicinecited by 268

PMID 35210595PMC8938269DOI 10.1038/s41591-022-01707-4PUB-35210595

CC BY4 results
Download PDFSee results (4)

Indexing hint: Randomized controlled trial · 2020

10 results

Effects of Novel Dual GIP and GLP-1 Receptor Agonist Tirzepatide on Biomarkers of Nonalcoholic Steatohepatitis in Patients With Type 2 Diabetes.

Hartman et al. 2020Diabetes carecited by 283

PMID 32291277PMC7245348DOI 10.2337/dc19-1892PUB-32291277

Rights unknown10 results
Source linkSee results (10)

Indexing hint: Randomized controlled trial · 2018

33 results

Efficacy and safety of LY3298176, a novel dual GIP and GLP-1 receptor agonist, in patients with type 2 diabetes: a randomised, placebo-controlled and active comparator-controlled phase 2 trial.

Frias et al. 2018Lancet (London, England)cited by 651

PMID 30293770DOI 10.1016/s0140-6736(18)32260-8PUB-30293770

Full text at the publisher33 results
Publisher pageSee results (33)

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 had type 2 diabetes (T2D) for ≥6 months according to the World Health Organization (WHO) classification. * 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) ≥23 and \<50 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. * 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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