A Study of Tirzepatide (LY3298176) in Participants With T... | NCT03131687

NCT03131687

ID	Type	Description	Link
I8F-MC-GPGB	Other Identifier	Eli Lilly and Company
2016-004179-33	EudraCT Number

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	Tirzepatide placebo and dulaglutide placebo administered subcutaneously (SC) once weekly.	Drug: Placebo
1 mg Tirzepatide	Experimental	1 milligrams (mg) tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.	Drug: tirzepatide Drug: Placebo
5 mg Tirzepatide	Experimental	5 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.	Drug: tirzepatide Drug: Placebo
10 mg Tirzepatide	Experimental	10 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.	Drug: tirzepatide Drug: Placebo
15 mg Tirzepatide	Experimental	15 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.	Drug: tirzepatide Drug: Placebo
1.5 mg Dulaglutide

Name	Type	Description	Arm Group Labels	Other Names
tirzepatide	Drug	Administered SC	1 mg Tirzepatide 10 mg Tirzepatide 15 mg Tirzepatide 5 mg Tirzepatide

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline to Week 26 in Hemoglobin A1c (HbA1c) Bayesian Dose Response	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.	Baseline, Week 26

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline to Week 12 in Hemoglobin A1c (HbA1c) Bayesian Dose Response	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.

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)	Eli Lilly and Company	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Internal Medicine Center LLC		Mobile	Alabama	36608	United States
Anaheim Clinical Trails

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35210595	Derived	Sattar N, McGuire DK, Pavo I, Weerakkody GJ, Nishiyama H, Wiese RJ, Zoungas S. Tirzepatide cardiovascular event risk assessment: a pre-specified meta-analysis. Nat Med. 2022 Mar;28(3):591-598. doi: 10.1038/s41591-022-01707-4. Epub 2022 Feb 24.
34608929	Derived	Pirro V, Roth KD, Lin Y, Willency JA, Milligan PL, Wilson JM, Ruotolo G, Haupt A, Newgard CB, Duffin KL. Effects of Tirzepatide, a Dual GIP and GLP-1 RA, on Lipid and Metabolite Profiles in Subjects With Type 2 Diabetes. J Clin Endocrinol Metab. 2022 Jan 18;107(2):363-378. doi: 10.1210/clinem/dgab722.

Label	URL
A Study of tirzepatide in Participants With Type 2 Diabetes Mellitus	View source

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Placebo	Tirzepatide placebo and dulaglutide placebo administered subcutaneously (SC) once weekly.
FG001	1 mg Tirzepatide	1 milligrams (mg) tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Nov 28, 2017	Jul 31, 2019

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

All randomized participants who received at least one dose of study drug.

Arm/Group Information

ID	Title	Description
BG000	Placebo	Tirzepatide placebo and dulaglutide placebo administered subcutaneously (SC) once weekly.
BG001	1 mg Tirzepatide	1 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
BG002	5 mg Tirzepatide	5 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
BG003	10 mg Tirzepatide	10 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
BG004	15 mg Tirzepatide	15 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
BG005	1.5 mg Dulaglutide	1.5 mg Dulaglutide administered SC once weekly. Tirzepatide placebo administered SC once weekly.
BG006	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00056.6± 8.85 BG00157.4± 8.85 BG00257.9± 8.22 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00022 BG00123 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00027 BG00125 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0005 BG0014 BG002

Region of Enrollment

Count of Participants

Participants

Title

Denominators

Categories

Puerto Rico

Title	Measurements
	BG0004 BG0014 BG002

Hemoglobin A1C (HbA1c) at Baseline

HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time.

Mean

Standard Deviation

Percentage of HbA1c

Title

Denominators

Categories

Title	Measurements
	BG0008.04± 0.861 BG0018.21

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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

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.

All randomized participants who received at least one dose of study drug and had a baseline and postbaseline excluding data after rescue drug initiation.

Posted

Least Squares Mean

Standard Deviation

Percentage of HbA1c

Baseline, Week 26

ID	Title	Description
OG000	Placebo	Tirzepatide placebo and dulaglutide placebo administered subcutaneously (SC) once weekly.
OG001	1 mg Tirzepatide	1 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
OG002	5 mg Tirzepatide	5 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
OG003	10 mg Tirzepatide	10 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
OG004	15 mg Tirzepatide	15 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
OG005	1.5 mg Dulaglutide	1.5 mg Dulaglutide administered SC once weekly. Tirzepatide placebo administered SC once weekly.

Units	Counts
Participants	OG00044 OG00145 OG00252 OG003

Title

Denominators

Categories

Title	Measurements
	OG000-0.06± 0.14 OG001-1.06± 0.11 OG002-1.73± 0.08 OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001						Posterior Mean Difference	-1.00	Standard Deviation	0.17	2-Sided						Statistics are estimated from a Bayesian hierarchical logistic dose response model along with a titrated integrated two-component prediction model to estimate missing values.		Other
OG000 OG002

Secondary

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

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.

All randomized participants who received at least one dose of study drug and had a baseline and postbaseline value excluding data after rescue drug initiation.

Posted

Least Squares Mean

Standard Deviation

Percentage of HbA1c

Baseline, Week 12

ID	Title	Description
OG000	Placebo	Tirzepatide placebo and dulaglutide placebo administered subcutaneously (SC) once weekly.
OG001	1 mg Tirzepatide	1 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
OG002	5 mg Tirzepatide	5 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
OG003

Secondary

Change From Baseline to Week 26 in HbA1c

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.

All randomized participants who received at least one dose of study drug who had a baseline and postbaseline value excluding data after study drug discontinuation or rescue drug initiation.

Posted

Least Squares Mean

Standard Error

Percentage of HbA1c

Baseline, Week 26

ID	Title	Description
OG000	Placebo	Tirzepatide placebo and dulaglutide placebo administered subcutaneously (SC) once weekly.
OG001	1 mg Tirzepatide	1 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
OG002	5 mg Tirzepatide	5 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
OG003	10 mg Tirzepatide

Secondary

Change From Baseline to Week 12 in HbA1c

randomized participants who received at least one dose of study drug who had a baseline and postbaseline value excluding data after study drug discontinuation or rescue drug initiation.

Posted

Least Squares Mean

Standard Error

Percentage of HbA1c

Baseline, Week 12

ID	Title	Description
OG000	Placebo	Tirzepatide placebo and dulaglutide placebo administered subcutaneously (SC) once weekly.
OG001	1 mg Tirzepatide	1 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
OG002	5 mg Tirzepatide	5 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
OG003	10 mg Tirzepatide

Secondary

Change From Baseline in Body Weight

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.

All randomized participants who received at least one dose of study drug and had a baseline and postbaseline value excluding data after study drug discontinuation or rescue drug initiation.

Posted

Least Squares Mean

Standard Error

Kilograms (Kg)

Baseline, Week 26

ID	Title	Description
OG000	Placebo	Tirzepatide placebo and dulaglutide placebo administered subcutaneously (SC) once weekly.
OG001	1 mg Tirzepatide	1 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
OG002	5 mg Tirzepatide	5 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
OG003	10 mg Tirzepatide	10 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.

Secondary

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

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.

All randomized participants who received at least one dose of study drug.

Posted

Number

percentage of participants

Week 26

ID	Title	Description
OG000	Placebo	Tirzepatide placebo and dulaglutide placebo administered subcutaneously (SC) once weekly.
OG001	1 mg Tirzepatide	1 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
OG002	5 mg Tirzepatide	5 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
OG003	10 mg Tirzepatide	10 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.

Secondary

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

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.

All randomized participants who received at least one dose of study drug.

Posted

Number

percentage of participants

Week 26

ID	Title	Description
OG000	Placebo	Tirzepatide placebo and dulaglutide placebo administered subcutaneously (SC) once weekly.
OG001	1 mg Tirzepatide	1 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
OG002	5 mg Tirzepatide	5 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
OG003	10 mg Tirzepatide	10 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.

Secondary

Percentage of Participants Reaching the HbA1c Target of ≤6.5%

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.

All randomized participants who received at least one dose of study drug excluding data after study drug discontinuation or rescue drug initiation.

Posted

Number

percentage of participants

Week 26

ID	Title	Description
OG000	Placebo	Tirzepatide placebo and dulaglutide placebo administered subcutaneously (SC) once weekly.
OG001	1 mg Tirzepatide	1 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
OG002	5 mg Tirzepatide	5 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
OG003	10 mg Tirzepatide	10 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.

Secondary

Percentage of Participants Reaching the HbA1c Target of <7.0%

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.

All randomized participants who received at least one dose of study drug excluding data after study drug discontinuation or rescue drug initiation.

Posted

Number

percentage of participants

Week 26

ID	Title	Description
OG000	Placebo	Tirzepatide placebo and dulaglutide placebo administered subcutaneously (SC) once weekly.
OG001	1 mg Tirzepatide	1 mg tirzepatide administered SC. Dulaglutide placebo administered SC once weekly.
OG002	5 mg Tirzepatide	5 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
OG003	10 mg Tirzepatide	10 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.

Secondary

Change From Baseline in Fasting Blood Glucose

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.

All randomized participants who received at least one dose of study drug who had a baseline and postbaseline value excluding data after study drug discontinuation or rescue drug initiation.

Posted

Least Squares Mean

Standard Error

milligrams per deciliter (mg/dL)

Baseline, Week 26

ID	Title	Description
OG000	Placebo	Tirzepatide placebo and dulaglutide placebo administered subcutaneously (SC) once weekly.
OG001	1 mg Tirzepatide	1 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
OG002	5 mg Tirzepatide	5 mg tirzepatide administered SC. Dulaglutide placebo administered SC.
OG003	10 mg Tirzepatide	10 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.

Secondary

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

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

All randomized participants who received at least one dose of study drug and had a baseline and postbaseline value.

Posted

Least Squares Mean

Standard Error

Millimoles Per Litre (mmol/L)

Baseline, Week 26

ID	Title	Description
OG000	Placebo	Tirzepatide placebo and dulaglutide placebo administered subcutaneously (SC) once weekly.
OG001	1 mg Tirzepatide	1 mg tirzepatide administered SC. Dulaglutide placebo administered SC once weekly.
OG002	5 mg Tirzepatide	5 mg tirzepatide administered SC. Dulaglutide placebo administered SC once weekly.
OG003	10 mg Tirzepatide	10 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.

Secondary

Change From Baseline in Total Cholesterol

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

All randomized participants who received at least one dose of study drug and had a baseline and postbaseline value.

Posted

Least Squares Mean

Standard Error

Millimoles Per Litre (mmol/L)

Baseline, Week 26

ID	Title	Description
OG000	Placebo	Tirzepatide placebo and dulaglutide placebo administered subcutaneously (SC) once weekly.
OG001	1 mg Tirzepatide	1 mg tirzepatide administered SC. Dulaglutide placebo administered SC once weekly.
OG002	5 mg Tirzepatide	5 mg tirzepatide administered SC. Dulaglutide placebo administered SC once weekly.
OG003	10 mg Tirzepatide	10 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.

Secondary

Change From Baseline in Triglycerides

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

All randomized participants who received at least one dose of study drug and had a baseline and postbaseline value.

Posted

Least Squares Mean

Standard Error

Millimoles Per Litre (mmol/L)

Baseline, Week 26

ID	Title	Description
OG000	Placebo	Tirzepatide placebo and dulaglutide placebo administered subcutaneously (SC) once weekly.
OG001	1 mg Tirzepatide	1 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
OG002	5 mg Tirzepatide	5 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
OG003	10 mg Tirzepatide	10 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.

Secondary

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

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

All randomized participants who received at least one dose of study drug and had a baseline and postbaseline value.

Posted

Least Squares Mean

Standard Error

Millimoles Per Litre (mmol/L)

Baseline, Week 26

ID	Title	Description
OG000	Placebo	Tirzepatide placebo and dulaglutide placebo administered SC once weekly.
OG001	1 mg Tirzepatide	1 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
OG002	5 mg Tirzepatide	5 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
OG003	10 mg Tirzepatide	10 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.

Secondary

Change From Baseline in Waist Circumference

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

All randomized participants who received at least one dose of study drug and had a baseline and postbaseline value.

Posted

Least Squares Mean

Standard Error

centimeters (cm)

Baseline, Week 26

ID	Title	Description
OG000	Placebo	Tirzepatide placebo and dulaglutide placebo administered SC once weekly.
OG001	1 mg Tirzepatide	1 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
OG002	5 mg Tirzepatide	5 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
OG003	10 mg Tirzepatide	10 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.

Secondary

Number of Participants With Anti-Drug Antibodies

Number of Participants With Anti-Drug Antibodies.

All randomized participants who received at least one dose of study drug.

Posted

Count of Participants

Participants

Baseline through Week 30

ID	Title	Description
OG000	Placebo	Tirzepatide placebo and dulaglutide placebo administered subcutaneously (SC).
OG001	1 mg Tirzepatide	1 mg tirzepatide administered SC. Dulaglutide placebo administered SC.
OG002	5 mg Tirzepatide	5 mg tirzepatide administered SC. Dulaglutide placebo administered SC.
OG003	10 mg Tirzepatide	10 mg tirzepatide administered SC. Dulaglutide placebo administered SC.
OG004	15 mg Tirzepatide

Secondary

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

All randomized participants who received at least one dose of Tirzepatide study drug excluding post rescue data.

Posted

Geometric Mean

Geometric Coefficient of Variation

Nanograms Per Millilitre (ng/mL)

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

ID	Title	Description
OG000	1 mg Tirzepatide	1 mg tirzepatide administered SC. Dulaglutide placebo administered SC.
OG001	5 mg Tirzepatide	5 mg tirzepatide administered SC. Dulaglutide placebo administered SC.
OG002	10 mg Tirzepatide	10 mg tirzepatide administered SC. Dulaglutide placebo administered SC.
OG003	15 mg Tirzepatide	15 mg tirzepatide administered SC. Dulaglutide placebo administered SC.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Tirzepatide placebo and dulaglutide placebo administered (SC) once weekly.	0	51	2	51	17	51
EG001	1 mg Tirzepatide	1 mg tirzepatide and placebo given SC once weekly.	1	52	2	52	17	52
EG002	5 mg Tirzepatide	5 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.	0	55	1	55	29	55
EG003	10 mg Tirzepatide	10 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.	0	51	3	51	32	51
EG004	15 mg Tirzepatide + Placebo	15 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.	0	53	2	53	39	53
EG005	1.5 mg Dulaglutide	1.5 mg Dulaglutide administered SC once weekly. Tirzepatide placebo administered SC once weekly.	0	54	3	54	31	54

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Coronary artery disease	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0010 events0 affected52 at risk EG0020 events0 affected55 at risk EG0030 events0 affected51 at risk EG0040 events0 affected53 at risk EG0051 events1 affected54 at risk
Coronary artery occlusion	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected52 at risk EG0020 events0 affected55 at risk EG003
Torsade de pointes	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected52 at risk EG0020 events0 affected55 at risk EG003
Ventricular fibrillation	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected52 at risk EG0020 events0 affected55 at risk EG003
Enteritis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0010 events0 affected52 at risk EG0020 events0 affected55 at risk EG003
Mesenteric vein thrombosis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0010 events0 affected52 at risk EG0020 events0 affected55 at risk EG003
Pancreatitis acute	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0010 events0 affected52 at risk EG0022 events1 affected55 at risk EG003
Cholecystitis	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0010 events0 affected52 at risk EG0020 events0 affected55 at risk EG003
Cholecystitis acute	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0010 events0 affected52 at risk EG0020 events0 affected55 at risk EG003
Perirectal abscess	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0010 events0 affected52 at risk EG0020 events0 affected55 at risk EG003
Pneumonia	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected51 at risk EG0010 events0 affected52 at risk EG0020 events0 affected55 at risk EG003
Urosepsis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected52 at risk EG0020 events0 affected55 at risk EG003
Lactic acidosis	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected52 at risk EG0020 events0 affected55 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0010 events0 affected52 at risk EG0020 events0 affected55 at risk EG003
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected52 at risk EG0020 events0 affected55 at risk EG003
Lung adenocarcinoma stage iv	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected52 at risk EG0020 events0 affected55 at risk EG003
Cluster headache	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0010 events0 affected52 at risk EG0020 events0 affected55 at risk EG003
Transient ischaemic attack	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0010 events0 affected52 at risk EG0020 events0 affected55 at risk EG003
Vertebrobasilar insufficiency	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0010 events0 affected52 at risk EG0020 events0 affected55 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0010 events0 affected52 at risk EG0020 events0 affected55 at risk EG003
Accelerated hypertension	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0010 events0 affected52 at risk EG0020 events0 affected55 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal discomfort	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected51 at risk EG0010 events0 affected52 at risk EG0021 events1 affected55 at risk EG0032 events1 affected51 at risk EG0047 events4 affected53 at risk EG0050 events0 affected54 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected52 at risk EG0022 events2 affected55 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected52 at risk EG0021 events1 affected55 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected52 at risk EG0022 events2 affected55 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected51 at risk EG00113 events7 affected52 at risk EG00217 events13 affected55 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0010 events0 affected52 at risk EG0022 events1 affected55 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected51 at risk EG0012 events2 affected52 at risk EG00217 events11 affected55 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected51 at risk EG0012 events2 affected52 at risk EG0028 events4 affected55 at risk EG003
Bronchitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0004 events3 affected51 at risk EG0011 events1 affected52 at risk EG0021 events1 affected55 at risk EG003
Influenza	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected51 at risk EG0012 events2 affected52 at risk EG0022 events2 affected55 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0003 events2 affected51 at risk EG0012 events1 affected52 at risk EG0023 events3 affected55 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected51 at risk EG0011 events1 affected52 at risk EG0023 events3 affected55 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0012 events2 affected52 at risk EG0022 events2 affected55 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected51 at risk EG0010 events0 affected52 at risk EG0023 events3 affected55 at risk EG003
Amylase increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected52 at risk EG0023 events2 affected55 at risk EG003
Lipase increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected51 at risk EG0011 events1 affected52 at risk EG0023 events3 affected55 at risk EG003
Weight decreased	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0012 events2 affected52 at risk EG0022 events2 affected55 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected51 at risk EG0012 events2 affected52 at risk EG00212 events11 affected55 at risk EG003
Dizziness	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0003 events2 affected51 at risk EG0014 events4 affected52 at risk EG0022 events2 affected55 at risk EG003
Headache	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected51 at risk EG0012 events2 affected52 at risk EG0022 events2 affected55 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected51 at risk EG0011 events1 affected52 at risk EG0021 events1 affected55 at risk EG003
Hypertension	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected52 at risk EG0020 events0 affected55 at risk EG003

ID	Term
D003924	Diabetes Mellitus, Type 2

ID	Term
D000098860	Tirzepatide
C555680	dulaglutide

Ancestor Terms

ID	Term
D000067757	Glucagon-Like Peptide-1 Receptor
D000067756	Glucagon-Like Peptide Receptors
D043562	Receptors, G-Protein-Coupled
D011956	Receptors, Cell Surface
D008565	Membrane Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D011964	Receptors, Gastrointestinal Hormone
D018000	Receptors, Peptide

15 mg tirzepatide administered SC. Dulaglutide placebo administered SC.

Units	Counts
Participants	OG00052 OG00155 OG00251 OG00353

EG0040 events0 affected53 at risk

EG0050 events0 affected54 at risk

EG0040 events0 affected53 at risk

EG0050 events0 affected54 at risk

EG0040 events0 affected53 at risk

EG0050 events0 affected54 at risk

EG0041 events1 affected53 at risk

EG0050 events0 affected54 at risk

EG0040 events0 affected53 at risk

EG0050 events0 affected54 at risk

EG0040 events0 affected53 at risk

EG0050 events0 affected54 at risk

EG0040 events0 affected53 at risk

EG0051 events1 affected54 at risk

EG0040 events0 affected53 at risk

EG0050 events0 affected54 at risk

EG0041 events1 affected53 at risk

EG0050 events0 affected54 at risk

EG0040 events0 affected53 at risk

EG0050 events0 affected54 at risk

EG0040 events0 affected53 at risk

EG0050 events0 affected54 at risk

EG0040 events0 affected53 at risk

EG0050 events0 affected54 at risk

EG0040 events0 affected53 at risk

EG0051 events1 affected54 at risk

EG0040 events0 affected53 at risk

EG0050 events0 affected54 at risk

EG0040 events0 affected53 at risk

EG0050 events0 affected54 at risk

EG0040 events0 affected53 at risk

EG0051 events1 affected54 at risk

EG0041 events1 affected53 at risk

EG0050 events0 affected54 at risk

EG0041 events1 affected53 at risk

EG0050 events0 affected54 at risk

EG0040 events0 affected53 at risk

EG0050 events0 affected54 at risk

EG0041 events1 affected53 at risk

EG0050 events0 affected54 at risk

EG0044 events4 affected53 at risk

EG0053 events3 affected54 at risk

EG0043 events3 affected53 at risk

EG0051 events1 affected54 at risk

EG0042 events2 affected53 at risk

EG0053 events3 affected54 at risk

EG00423 events17 affected53 at risk

EG00512 events9 affected54 at risk

EG0042 events2 affected53 at risk

EG0052 events2 affected54 at risk

EG00429 events21 affected53 at risk

EG00522 events16 affected54 at risk

EG00420 events14 affected53 at risk

EG0056 events5 affected54 at risk

EG0040 events0 affected53 at risk

EG0052 events2 affected54 at risk

EG0041 events1 affected53 at risk

EG0052 events2 affected54 at risk

EG0046 events3 affected53 at risk

EG0056 events6 affected54 at risk

EG0041 events1 affected53 at risk

EG0055 events4 affected54 at risk

EG0044 events4 affected53 at risk

EG0050 events0 affected54 at risk

EG0040 events0 affected53 at risk

EG0051 events1 affected54 at risk

EG0043 events1 affected53 at risk

EG0050 events0 affected54 at risk

EG0043 events2 affected53 at risk

EG0051 events1 affected54 at risk

EG0042 events2 affected53 at risk

EG0050 events0 affected54 at risk

EG00413 events10 affected53 at risk

EG0053 events3 affected54 at risk

EG0045 events5 affected53 at risk

EG0051 events1 affected54 at risk

EG0045 events5 affected53 at risk

EG0051 events1 affected54 at risk

EG0043 events3 affected53 at risk

EG0051 events1 affected54 at risk

EG0041 events1 affected53 at risk

EG0053 events3 affected54 at risk

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases