NCT03131687 is a Phase 2 clinical trial of tirzepatide in Type 2 Diabetes Mellitus, sponsored by Eli Lilly and Company.

Who is sponsoring NCT03131687?

NCT03131687 is sponsored by Eli Lilly and Company.

What drugs are being tested in NCT03131687?

Interventions in NCT03131687: tirzepatide, Dulaglutide, Placebo.

What condition does NCT03131687 study?

NCT03131687 studies Type 2 Diabetes Mellitus.

Is NCT03131687 still recruiting?

NCT03131687 is currently completed. Last updated 20 August 2019.

Are results published for NCT03131687?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-08-20 · How we verify

NCT03131687

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 2 Results posted Last updated 20 August 2019

What this trial tests

Phase 2 trial testing tirzepatide in Type 2 Diabetes Mellitus in 318 participants. Completed in 1 August 2018.

Timeline

24 May 2017

Primary endpoint
1 August 2018

1 August 2018

Quick facts

Lead sponsor	Eli Lilly and Company
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	318
Start date	24 May 2017
Primary completion	1 August 2018
Estimated completion	1 August 2018
Sites	49 locations across Slovakia, Puerto Rico, United States, Poland

Drugs / interventions tested

tirzepatide (TIRZEPATIDE) — full drug profile →
Dulaglutide (DULAGLUTIDE) — full drug profile →
Placebo

Conditions studied

Type 2 Diabetes Mellitus — all drugs for Type 2 Diabetes Mellitus →

Sponsor

Eli Lilly and Company — full company profile →

Who can join

Adults 18 to 75, any sex, with Type 2 Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

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.

Group	Value	95% CI
Placebo	-0.06	± 0.14
1 mg Tirzepatide	-1.06	± 0.11
5 mg Tirzepatide	-1.73	± 0.08
10 mg Tirzepatide	-1.89	± 0.08
15 mg Tirzepatide	-1.94	± 0.09
1.5 mg Dulaglutide	-1.21	± 0.14

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

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.

Group	Value	95% CI
Placebo	-0.05	± 0.13
1 mg Tirzepatide	-0.94	± 0.10
5 mg Tirzepatide	-1.54	± 0.07
10 mg Tirzepatide	-1.68	± 0.08
15 mg Tirzepatide	-1.72	± 0.08
1.5 mg Dulaglutide	-1.08	± 0.13

Change From Baseline to Week 26 in HbA1c Secondary · Baseline, Week 26

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.

Group	Value	95% CI
Placebo	0.1	± 0.16
1 mg Tirzepatide	-0.7	± 0.16
5 mg Tirzepatide	-1.6	± 0.15
10 mg Tirzepatide	-2.0	± 0.16
15 mg Tirzepatide	-2.4	± 0.17
1.5 mg Dulaglutide	-1.1	± 0.15

Change From Baseline to Week 12 in HbA1c Secondary · Baseline, Week 12

Group	Value	95% CI
Placebo	-0.1	± 0.13
1 mg Tirzepatide	-0.9	± 0.13
5 mg Tirzepatide	-1.7	± 0.13
10 mg Tirzepatide	-2.0	± 0.13
15 mg Tirzepatide	-2.1	± 0.15
1.5 mg Dulaglutide	-1.2	± 0.13

Change From Baseline in Body Weight Secondary · Baseline, Week 26

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.

Group	Value	95% CI
Placebo	-0.4	± 0.81
1 mg Tirzepatide	-0.9	± 0.80
5 mg Tirzepatide	-4.8	± 0.77
10 mg Tirzepatide	-8.7	± 0.80
15 mg Tirzepatide	-11.3	± 0.88
1.5 mg Dulaglutide	-2.7	± 0.78

Percentage of Participants With 5% or Greater Body Weight Loss From Baseline Secondary · Week 26

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.

Group	Value	95% CI
Placebo	0
1 mg Tirzepatide	13.5
5 mg Tirzepatide	47.3
10 mg Tirzepatide	70.6
15 mg Tirzepatide	62.3
1.5 mg Dulaglutide	22.2

Percentage of Participants With 10% or Greater Body Weight Loss From Baseline Secondary · Week 26

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.

Group	Value	95% CI
Placebo	0
1 mg Tirzepatide	5.8
5 mg Tirzepatide	16.4
10 mg Tirzepatide	39.2
15 mg Tirzepatide	37.7
1.5 mg Dulaglutide	9.3

Percentage of Participants Reaching the HbA1c Target of ≤6.5% Secondary · Week 26

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.

Group	Value	95% CI
Placebo	2.0
1 mg Tirzepatide	15.4
5 mg Tirzepatide	63.6
10 mg Tirzepatide	82.0
15 mg Tirzepatide	58.5
1.5 mg Dulaglutide	38.9

Percentage of Participants Reaching the HbA1c Target of <7.0% Secondary · Week 26

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.

Group	Value	95% CI
Placebo	11.8
1 mg Tirzepatide	32.7
5 mg Tirzepatide	69.1
10 mg Tirzepatide	90.0
15 mg Tirzepatide	77.4
1.5 mg Dulaglutide	51.9

Change From Baseline in Fasting Blood Glucose Secondary · Baseline, Week 26

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.

Group	Value	95% CI
Placebo	15.5	± 6.66
1 mg Tirzepatide	-6.8	± 6.43
5 mg Tirzepatide	-40.7	± 6.23
10 mg Tirzepatide	-60.7	± 6.36
15 mg Tirzepatide	-57.5	± 7.10
1.5 mg Dulaglutide	-21.2	± 6.40

Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) Secondary · Baseline, Week 26

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

Group	Value	95% CI
Placebo	0.0	± 0.03
1 mg Tirzepatide	-0.0	± 0.03
5 mg Tirzepatide	0.0	± 0.03
10 mg Tirzepatide	0.0	± 0.03
15 mg Tirzepatide	0.1	± 0.03
1.5 mg Dulaglutide	0.0	± 0.03

Change From Baseline in Total Cholesterol Secondary · Baseline, Week 26

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

Group	Value	95% CI
Placebo	0.3	± 0.13
1 mg Tirzepatide	0.2	± 0.13
5 mg Tirzepatide	-0.1	± 0.12
10 mg Tirzepatide	-0.3	± 0.12
15 mg Tirzepatide	-0.3	± 0.13
1.5 mg Dulaglutide	-0.2	± 0.12

Adverse events — posted to ClinicalTrials.gov

Time frame: Up To 34 Weeks. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo

Serious: 2/51 (4%)

Deaths: 0/51

1 mg Tirzepatide

Serious: 2/52 (4%)

Deaths: 1/52

5 mg Tirzepatide

Serious: 1/55 (2%)

Deaths: 0/55

10 mg Tirzepatide

Serious: 3/51 (6%)

Deaths: 0/51

15 mg Tirzepatide + Placebo

Serious: 2/53 (4%)

Deaths: 0/53

1.5 mg Dulaglutide

Serious: 3/54 (6%)

Deaths: 0/54

Serious adverse events (21 terms)

Reaction	System	Placebo	1 mg Tirzepatide	5 mg Tirzepatide	10 mg Tirzepatide	15 mg Tirzepatide + Placebo	1.5 mg Dulaglutide
Pneumonia	Infections and infestations	—	—	—	—	—	—
Coronary artery disease	Cardiac disorders	—	—	—	—	—	—
Coronary artery occlusion	Cardiac disorders	—	—	—	—	—	—
Torsade de pointes	Cardiac disorders	—	—	—	—	—	—
Ventricular fibrillation	Cardiac disorders	—	—	—	—	—	—
Enteritis	Gastrointestinal disorders	—	—	—	—	—	—
Mesenteric vein thrombosis	Gastrointestinal disorders	—	—	—	—	—	—
Pancreatitis acute	Gastrointestinal disorders	—	—	—	—	—	—
Cholecystitis	Hepatobiliary disorders	—	—	—	—	—	—
Cholecystitis acute	Hepatobiliary disorders	—	—	—	—	—	—
Perirectal abscess	Infections and infestations	—	—	—	—	—	—
Urosepsis	Infections and infestations	—	—	—	—	—	—
Lactic acidosis	Metabolism and nutrition disorders	—	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—
Pathological fracture	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—
Lung adenocarcinoma stage iv	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—
Cluster headache	Nervous system disorders	—	—	—	—	—	—
Transient ischaemic attack	Nervous system disorders	—	—	—	—	—	—
Vertebrobasilar insufficiency	Nervous system disorders	—	—	—	—	—	—
Acute kidney injury	Renal and urinary disorders	—	—	—	—	—	—
Accelerated hypertension	Vascular disorders	—	—	—	—	—	—

Other adverse events (22 terms — click to expand)

Reaction	System	Placebo	1 mg Tirzepatide	5 mg Tirzepatide	10 mg Tirzepatide	15 mg Tirzepatide + Placebo	1.5 mg Dulaglutide
Nausea	Gastrointestinal disorders	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—	—	—
Abdominal distension	Gastrointestinal disorders	—	—	—	—	—	—
Weight decreased	Investigations	—	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—
Abdominal discomfort	Gastrointestinal disorders	—	—	—	—	—	—
Influenza	Infections and infestations	—	—	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—	—	—
Amylase increased	Investigations	—	—	—	—	—	—
Lipase increased	Investigations	—	—	—	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—	—	—	—
Bronchitis	Infections and infestations	—	—	—	—	—	—
Contusion	Injury, poisoning and procedural complications	—	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—
Hypertension	Vascular disorders	—	—	—	—	—	—

Most-reported serious reactions: Pneumonia, Coronary artery disease, Coronary artery occlusion, Torsade de pointes, Ventricular fibrillation, Enteritis, Mesenteric vein thrombosis, Pancreatitis acute.

Data from ClinicalTrials.gov NCT03131687 adverse events section.

Sponsor's own description

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

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

LY3298176, a novel dual GIP and GLP-1 receptor agonist for the treatment of type 2 diabetes mellitus: From discovery to clinical proof of concept.
Coskun T, Sloop KW, Loghin C, Alsina-Fernandez J, et al · · 2018 · cited 582× · PMID 30473097 · DOI 10.1016/j.molmet.2018.09.009
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 JP, Nauck MA, Van J, Kutner ME, et al · · 2018 · cited 573× · PMID 30293770 · DOI 10.1016/s0140-6736(18)32260-8
Targeting fibrosis, mechanisms and cilinical trials.
Zhao M, Wang L, Wang M, Zhou S, et al · · 2022 · cited 352× · PMID 35773269 · DOI 10.1038/s41392-022-01070-3
Dual GIP and GLP-1 Receptor Agonist Tirzepatide Improves Beta-cell Function and Insulin Sensitivity in Type 2 Diabetes.
Thomas MK, Nikooienejad A, Bray R, Cui X, et al · · 2021 · cited 251× · PMID 33236115 · DOI 10.1210/clinem/dgaa863
Effects of Novel Dual GIP and GLP-1 Receptor Agonist Tirzepatide on Biomarkers of Nonalcoholic Steatohepatitis in Patients With Type 2 Diabetes.
Hartman ML, Sanyal AJ, Loomba R, Wilson JM, et al · · 2020 · cited 248× · PMID 32291277 · DOI 10.2337/dc19-1892
Tirzepatide cardiovascular event risk assessment: a pre-specified meta-analysis.
Sattar N, McGuire DK, Pavo I, Weerakkody GJ, et al · · 2022 · cited 239× · PMID 35210595 · DOI 10.1038/s41591-022-01707-4
Targeted therapeutics and novel signaling pathways in non-alcohol-associated fatty liver/steatohepatitis (NAFL/NASH).
Xu X, Poulsen KL, Wu L, Liu S, et al · · 2022 · cited 235× · PMID 35963848 · DOI 10.1038/s41392-022-01119-3
Management of type 2 diabetes with the dual GIP/GLP-1 receptor agonist tirzepatide: a systematic review and meta-analysis.
Karagiannis T, Avgerinos I, Liakos A, Del Prato S, et al · · 2022 · cited 179× · PMID 35579691 · DOI 10.1007/s00125-022-05715-4

Verify or expand the search:

Other trials of tirzepatide

Trials testing the same drug.

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Other recruiting trials for Type 2 Diabetes Mellitus

Currently open trials in the same condition.

NCT07351058 — A Clinical Study to Evaluate the Effects of RO7795068 in Participants With Obesity or Overweight and Type 2 Diabetes · Phase 3 · recruiting
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NCT07276776 — An Evaluation of the Omnipod® M System in Adults With Type 2 Diabetes · NA · active not recruiting
NCT07232537 — An Observational Study Called FINE-REAL Korea to Learn More About the Use of the Drug Finerenone in People With Chronic · recruiting

Other Eli Lilly and Company trials

Trials by the same sponsor.

NCT07533006 — A Study of LY4005130 in Adult Participants With Severe Alopecia Areata (Hair Loss) · Phase 2 · not yet recruiting
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NCT07247357 — A Study of LY4064809 in Healthy Adult Chinese Participants · Phase 1 · completed
NCT07124013 — A Study of Olomorasib (LY3537982) in Healthy Japanese Participants · Phase 1 · completed
NCT07030127 — A Study of LY3985863 in Healthy Participants · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03131687 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Eli Lilly and Company
Last refreshed: 20 August 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03131687.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing