A Study of Tirzepatide (LY3298176) in Participants With T... | NCT03311724

ID	Type	Description	Link
I8F-MC-GPGF	Other Identifier	Eli Lilly and Company

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
4,8,12mg Tirzepatide	Experimental	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.	Drug: Tirzepatide
2.5,5,10,15mg Tirzepatide	Experimental	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.	Drug: Tirzepatide
2.5,7.5,15mg Tirzepatide	Experimental	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.	Drug: Tirzepatide
Placebo	Placebo Comparator	Placebo administered by SC injection.	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Tirzepatide	Drug	Administered SC	2.5,5,10,15mg Tirzepatide 2.5,7.5,15mg Tirzepatide 4,8,12mg Tirzepatide

Measure	Description	Time Frame
Change From Baseline in Haemoglobin A1c (HbA1c)	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.	Baseline, 3 Months

Measure	Description	Time Frame
Percentage of Participants Achieving HbA1c Target of <7.0%	Percentage of participants achieving HbA1c target of < (less than) 7.0%.	3 Months
Change From Baseline in Fasting Blood Glucose (FBG)

Eligibility 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
Valley Research		Fresno	California	93720	United States
National Research Institute

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

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Placebo	Participants received Placebo by subcutaneous (SC) injection.
FG001	4, 8 and 12mg Tirzepatide	Participants 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.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Aug 2, 2017	Feb 13, 2020

Arm/Group Information

ID	Title	Description
BG000	Placebo	Placebo administered by SC injection.
BG001	4, 8 and 12mg Tirzepatide	Participants 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.
BG002	2.5, 5, 10, and 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.
BG003	2.5, 7.5 and 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.
BG004	Total	Total of all reporting groups

Units	Counts
Participants	BG00026 BG00129 BG00228 BG00328 BG004111

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
	BG00056.0± 10.13 BG00161.2± 7.56 BG00255.5± 8.54 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00014 BG00114 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00016 BG00115 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0012 BG002

Region of Enrollment

Count of Participants

Participants

Title

Denominators

Categories

United States

Title	Measurements
	BG00026 BG00129 BG002

Hemoglobin A1c (HbA1c)

Mean

Standard Deviation

Percentage of HbA1C

Title

Denominators

Categories

Title	Measurements
	BG0008.23± 1.22 BG0018.35± 0.897 BG002

Fasting Blood Glucose (FBG)

Mean

Standard Deviation

millimoles per liter (mmol/L)

Title

Denominators

Categories

Title	Measurements
	BG0009.68± 3.44 BG0019.76± 3.03 BG002

Body Weight

Mean

Standard Deviation

kilogram (kg)

Title

Denominators

Categories

Title	Measurements
	BG00089.58± 23.69 BG00187.98± 17.35 BG002

Waist Circumference

Mean

Standard Deviation

centimeter (cm)

Title

Denominators

Categories

Title	Measurements
	BG000109.09± 15.38 BG001107.65± 12.22 BG002

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 in Haemoglobin A1c (HbA1c)

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.

All participants who received at least 1 dose of study drug and had baseline and at least one post baseline data. Participants who discontinued study drug or initiated rescue drug were excluded.

Posted

Least Squares Mean

Standard Error

Percentage of HbA1C

Baseline, 3 Months

ID	Title	Description
OG000	Placebo	Placebo administered SC.
OG001	4, 8 and 12mg Tirzepatide	Participants 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.
OG002	2.5, 5, 10, and 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.
OG003	2.5, 7.5 and 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.

Units	Counts
Participants	OG00020 OG00127 OG00223 OG003

Title

Denominators

Categories

Title	Measurements
	OG0000.2± 0.21 OG001-1.7± 0.19 OG002-2.0± 0.20 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		Mixed Models Analysis		<0.001		Mean Difference (Final Values)	-1.9			2-Sided	95	-2.5	-1.4					Superiority
OG000 OG002		Mixed Models Analysis		<0.001

Secondary

Percentage of Participants Achieving HbA1c Target of <7.0%

Percentage of participants achieving HbA1c target of < (less than) 7.0%.

All participants who received at least 1 dose of study drug and had baseline and at least one post baseline data. Participants who discontinued study drug or initiated rescue drug were excluded.

Posted

Number

percentage of participants

3 Months

ID	Title	Description
OG000	Placebo	Placebo administered SC.
OG001	4, 8 and 12mg Tirzepatide	Participants 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.
OG002	2.5, 5, 10, and 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.
OG003	2.5, 7.5 and 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.

Secondary

Change From Baseline in Fasting Blood Glucose (FBG)

LSMean was calculated using MMRM model with baseline + baseline HbA1C group + baseline BMI group + baseline Metformin flag + treatment + time + treatment*time as fixed factors.

All participants who received at least 1 dose of study drug and had baseline and at least one post baseline data. Participants who discontinued study drug or initiated rescue drug were excluded.

Posted

Least Squares Mean

Standard Error

milligrams per deciliter (mg/dL)

Baseline, 3 Months

ID	Title	Description
OG000	Placebo	Placebo administered SC.
OG001	4, 8 and 12mg Tirzepatide	Participants 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.
OG002	2.5, 5, 10, and 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.
OG003	2.5, 7.5 and 15mg Tirzepatide

Secondary

Change From Baseline in Body Weight

LSMean was calculated using MMRM model with baseline + baseline HbA1C group + baseline BMI group + baseline Metformin flag + treatment + time + treatment*time as fixed factors.

All participants who received at least 1 dose of study drug and had baseline and at least one post baseline data. Participants who discontinued study drug or initiated rescue drug were excluded.

Posted

Least Squares Mean

Standard Error

kilogram (kg)

Baseline, 3 Months

ID	Title	Description
OG000	Placebo	Placebo administered SC.
OG001	4, 8 and 12mg Tirzepatide	Participants 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.
OG002	2.5, 5, 10, and 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.
OG003	2.5, 7.5 and 15mg Tirzepatide

Secondary

Change From Baseline in Waist Circumference

LSMean was calculated using MMRM model with baseline + baseline HbA1C group + baseline BMI group + baseline Metformin flag + treatment + time + treatment*time as fixed factors.

All participants who received at least 1 dose of study drug and had baseline and at least one post baseline data. Participants who discontinued study drug or initiated rescue drug were excluded.

Posted

Least Squares Mean

Standard Error

centimeter (cm)

Baseline, 3 Months

ID	Title	Description
OG000	Placebo	Placebo administered SC.
OG001	4, 8 and 12mg Tirzepatide	Participants 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.
OG002	2.5, 5, 10, and 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.
OG003	2.5, 7.5 and 15mg Tirzepatide

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

Number

participants

Baseline through 3 Months

ID	Title	Description
OG000	Placebo	Placebo administered SC.
OG001	4, 8 and 12mg Tirzepatide	Participants 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.
OG002	2.5, 5, 10, and 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.
OG003	2.5, 7.5 and 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.

Secondary

Number of Episodes of Total Hypoglycemia Episodes

Number of episodes of total hypoglycemia episodes with plasma glucose <= ( less than or equal to) 54 mg/dL.

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

Posted

Number

Episodes

Baseline through 3 Months

ID	Title	Description
OG000	Placebo	Placebo administered SC.
OG001	4, 8 and 12mg Tirzepatide	Participants 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.
OG002	2.5, 5, 10, and 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.
OG003	2.5, 7.5 and 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.

Secondary

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

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

All randomized participants who received at least one dose of study drug and had evaluable PK samples.

Posted

Mean

Standard Deviation

nanograms per milliliter (ng/mL)

Week 4, 8 12: Pre-dose

ID	Title	Description
OG000	4, 8 and 12mg Tirzepatide	Participants 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.
OG001	2.5, 5, 10, and 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.
OG002	2.5, 7.5 and 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.

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Placebo administered SC	26	0	26	7	26
EG001	4, 8 and 12mg Tirzepatide	Participants 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.	29	1	29	19	29
EG002	2.5, 5, 10, and 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.	28	0	28	18	28
EG003	2.5, 7.5 and 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.	28	0	28	22	28

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal distension	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected26 at risk EG0010 events0 affected29 at risk EG0029 events3 affected28 at risk EG0032 events2 affected28 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected26 at risk EG0011 events1 affected29 at risk EG0025 events5 affected28 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected26 at risk EG0013 events2 affected29 at risk EG0022 events1 affected28 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected26 at risk EG0011 events1 affected29 at risk EG0025 events3 affected28 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected26 at risk EG00118 events9 affected29 at risk EG00219 events10 affected28 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected26 at risk EG0017 events5 affected29 at risk EG00212 events3 affected28 at risk EG003
Eructation	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected26 at risk EG0013 events2 affected29 at risk EG0020 events0 affected28 at risk EG003
Flatulence	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected26 at risk EG0011 events1 affected29 at risk EG0023 events2 affected28 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected26 at risk EG0013 events2 affected29 at risk EG0021 events1 affected28 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected26 at risk EG00114 events7 affected29 at risk EG00218 events11 affected28 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected26 at risk EG0016 events5 affected29 at risk EG0027 events5 affected28 at risk EG003
Fatigue	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected26 at risk EG0011 events1 affected29 at risk EG0022 events2 affected28 at risk EG003
Injection site reaction	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected26 at risk EG0013 events2 affected29 at risk EG0022 events2 affected28 at risk EG003
Pharyngitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0003 events2 affected26 at risk EG0010 events0 affected29 at risk EG0020 events0 affected28 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected26 at risk EG0012 events2 affected29 at risk EG0020 events0 affected28 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected26 at risk EG0010 events0 affected29 at risk EG0022 events2 affected28 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected26 at risk EG0014 events4 affected29 at risk EG0027 events6 affected28 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected26 at risk EG0011 events1 affected29 at risk EG0020 events0 affected28 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected26 at risk EG0011 events1 affected29 at risk EG0020 events0 affected28 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected26 at risk EG0010 events0 affected29 at risk EG0022 events2 affected28 at risk EG003
Dizziness	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected26 at risk EG0010 events0 affected29 at risk EG0021 events1 affected28 at risk EG003
Headache	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected26 at risk EG0015 events2 affected29 at risk EG00210 events6 affected28 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected26 at risk EG0013 events2 affected29 at risk EG0022 events2 affected28 at risk EG003
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected26 at risk EG0012 events2 affected29 at risk EG0021 events1 affected28 at risk EG003

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

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