A Study of Tirzepatide (LY3298176) in Healthy Participant... | NCT02759107

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

A Study of Tirzepatide (LY3298176) in Healthy Participant... | NCT02759107 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Tirzepatide (Part A)	Experimental	Participants received escalating single doses of either 0.25 milligram (mg) or 0.5mg or 1mg, or 2.5mg or 5mg or 8mg Tirzepatide by subcutaneous injection.	Drug: Tirzepatide
Placebo (Part A)	Placebo Comparator	Participants received single dose of placebo by subcutaneous injection.	Drug: Placebo
Tirzepatide (Part B)	Experimental	Participants received fixed doses of either 0.5mg or 1.5mg or 4.5mg Tirzepatide once weekly for four weeks or titrated doses of 5mg, 5mg, 8mg and 10mg Tirzepatide once weekly for four weeks by subcutaneous injection.	Drug: Tirzepatide
Placebo (Part B)	Placebo Comparator	Participants received placebo once weekly for four weeks by subcutaneous injection.	Drug: Placebo
Dulaglutide (Part B)	Active Comparator	Participants received 1.5mg Dulaglutide once weekly for four weeks by subcutaneous injection.	Drug: Dulaglutide

Name	Type	Description	Arm Group Labels	Other Names
Tirzepatide	Drug	Administered SC	Tirzepatide (Part A) Tirzepatide (Part B) Tirzepatide (Part C)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With One or More Serious Adverse Event(s) (SAEs)	Number of participants with one or more SAEs considered by the investigator to be related to study drug administration. A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, were reported in the Reported Adverse Events module	Baseline through Day 43 (Part A) and Day 57 (Part B and C)

Secondary Outcomes

Measure	Description	Time Frame
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide in Part A.	Area under the concentration versus time curve from zero to infinity (AUC [0-∞]) of Tirzepatide in Part A.	Predose, 8hours(h), 24h,48h,72h,96h,120h,168h,336h postdose, day 29, day 43
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide in Part B

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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Miami Research Associates		South Miami	Florida	33143	United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30473097	Derived	Coskun T, Sloop KW, Loghin C, Alsina-Fernandez J, Urva S, Bokvist KB, Cui X, Briere DA, Cabrera O, Roell WC, Kuchibhotla U, Moyers JS, Benson CT, Gimeno RE, D'Alessio DA, Haupt A. 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. Mol Metab. 2018 Dec;18:3-14. doi: 10.1016/j.molmet.2018.09.009. Epub 2018 Oct 3.

Label	URL
Click here for more information about this study:A Study of tirzepatide in Participants With Type 2 Diabetes (T2DM)	View source

Arm/Group Information

ID	Title	Description
FG000	Part A Placebo	Participants received placebo by subcutaneous (SC) injection.
FG001	Part A 0.25 mg Tirzepatide	Participants received single dose of 0.25 milligram (mg) Tirzepatide by subcutaneous injection.
FG002	Part A 0.5mg Tirzepatide	Participants received single dose of 0.5mg Tirzepatide by subcutaneous injection.
FG003	Part A 1mg Tirzepatide	Participants received single dose of 1mg Tirzepatide by subcutaneous injection.
FG004	Part A 2.5mg Tirzepatide	Participants received single dose of 2.5mg Tirzepatide by subcutaneous injection.
FG005	Part A 5mg Tirzepatide	Participants received single dose of 5mg Tirzepatide by subcutaneous injection.
FG006	Part A 8mg Tirzepatide	Participants received single dose of 8mg Tirzepatide by subcutaneous injection.
FG007	Part B Placebo	Participants received placebo by subcutaneous injection.
FG008	Part B 1.5mg Dulaglutide	Participants received 1.5mg Dulaglutide once weekly for four weeks by subcutaneous injection.
FG009	Part B 0.5mg Tirzepatide	Participants received 0.5mg Tirzepatide once weekly for four weeks by subcutaneous injection.
FG010	Part B 1.5mg Tirzepatide	Participants received 1.5mg Tirzepatide once weekly for four weeks by subcutaneous injection.
FG011	Part B 4.5mg Tirzepatide	Participants received 4.5mg Tirzepatide once weekly for four weeks by subcutaneous injections.
FG012	Part B 5, 5, 8,10mg Tirzepatide	Participants received titrated doses of Tirzepatide once a week for four weeks by subcutaneous injection. 5mg QW followed by 5mg QW followed by 8mg QW followed by 10mg QW.
FG013	Part C Placebo	Participants received placebo by subcutaneous injection.
FG014	Part C 0.5mg Tirzepatide	Participants received 0.5mg Tirzepatide once weekly for four weeks by subcutaneous injection.
FG015	Part C 5mg Tirzepatide	Participants received 5mg Tirzepatide once weekly for four weeks by subcutaneous injection.
FG016	Part C 5, 5, 10,10mg Tirzepatide	Participants received titrated doses of Tirzepatide once a week for four weeks by subcutaneous injection. 5mg QW followed by 5mg QW followed by 10mg QW followed by 10mg QW.
FG017	Part C 5, 5, 10,15mg Tirzepatide	Participants received titrated doses of Tirzepatide once a week for four weeks by subcutaneous injection. 5mg QW followed by 5mg QW followed by 10mg QW followed by 15mg QW.

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG00014 subjects FG0016 subjects FG00212 subjects FG0035 subjects FG0046 subjects FG0056 subjects FG0067 subjects FG0074 subjects FG0084 subjects FG0096 subjects FG0106 subjects FG0116 subjects FG0127 subjects FG01311 subjects FG0149 subjects FG0159 subjects FG01612 subjects FG01712 subjects
Received at Least One Dose of Study Drug		FG00014 subjects FG0016 subjects FG00212 subjects FG0035 subjects
COMPLETED		FG00014 subjects FG0016 subjects FG00212 subjects FG0035 subjects FG004
NOT COMPLETED		FG0000 subjects FG0010 subjects FG0020 subjects FG0030 subjects FG004

Type	Comment	Reasons
Adverse Event		FG0000 subjects FG0010 subjects FG0020 subjects FG003

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Part A Placebo	Participants received placebo by subcutaneous (SC) injection.
BG001	Part A 0.25 mg Tirzepatide	Participants received single dose of 0.25mg Tirzepatide by subcutaneous injection.

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

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

Number of Participants With One or More Serious Adverse Event(s) (SAEs)

Number of participants with one or more SAEs considered by the investigator to be related to study drug administration. A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, were reported in the Reported Adverse Events module

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

Posted

Number

Participants

Baseline through Day 43 (Part A) and Day 57 (Part B and C)

ID	Title	Description
OG000	Tirzepatide (Part A)	Participants received escalating doses of either 0.25mg or 0.5mg or 1mg, or 2.5mg or 5mg or 8mg Tirzepatide once weekly for four weeks by subcutaneous injection.
OG001	Placebo (Part A)

Adverse Events Module

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	Part A - Placebo	Participants received placebo by subcutaneous (SC) injection.

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Atrioventricular block second degree	Cardiac disorders	MedDRA 18.1	Systematic Assessment

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Thrombocytosis	Blood and lymphatic system disorders	MedDRA 18.1	Systematic Assessment

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Chief Medical Officer	Eli Lilly and Company	800-545-5979		ClinicalTrials.gov@lilly.com

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Feb 6, 2017	Feb 25, 2020	Prot_000.pdf
SAP	No	Yes	No	Statistical Analysis Plan	May 4, 2016	Feb 25, 2020	SAP_001.pdf

Condition Browse Module

ID	Term
D003924	Diabetes Mellitus, Type 2

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

Intervention Browse Module

ID	Term
D000098860	Tirzepatide
C555680	dulaglutide

ID	Term
D000067757	Glucagon-Like Peptide-1 Receptor
D000067756	Glucagon-Like Peptide Receptors
D043562	Receptors, G-Protein-Coupled
D011956	Receptors, Cell Surface

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0000 BG0010 BG0020 BG0030 BG0040 BG0050 BG0060 BG0070 BG0080 BG0090 BG0100 BG0110 BG0120 BG0130 BG0140 BG0150 BG0160 BG0170 BG0180
Between 18 and 65 years	BG00014 BG0016 BG00212 BG0034 BG004
>=65 years	BG0000 BG0010 BG0020 BG0031 BG004

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0000 BG0011 BG0021 BG0031 BG0040 BG0050 BG0060 BG0070 BG0080 BG0090 BG0100 BG0116 BG0120 BG0134 BG0146 BG0157 BG0162 BG0176 BG01834
Male	BG00014 BG0015 BG00211 BG0034 BG004

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0000 BG0010 BG0020 BG0030 BG0040 BG0050 BG0060 BG0070 BG0080 BG0090 BG0100 BG0110 BG0120 BG01310 BG0149 BG0158 BG0167 BG01712 BG01846
Not Hispanic or Latino	BG00014 BG0016 BG00212 BG0035 BG004
Unknown or Not Reported	BG0000 BG0010 BG0020 BG0030 BG004

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG0020 BG0030 BG0040 BG0050 BG0060 BG0070 BG0080 BG0090 BG0100 BG0110 BG0120 BG0131 BG0140 BG0150 BG0160 BG0170 BG0181
Asian	BG00013 BG0016 BG00212 BG0035 BG004
Native Hawaiian or Other Pacific Islander	BG0000 BG0010 BG0020 BG0030 BG004
Black or African American	BG0000 BG0010 BG0020 BG0030 BG004
White	BG0001 BG0010 BG0020 BG0030 BG004
More than one race	BG0000 BG0010 BG0020 BG0030 BG004
Unknown or Not Reported	BG0000 BG0010 BG0020 BG0030 BG004

Region of Enrollment

Count of Participants

Participants

Title

Denominators

Categories

Singapore

Title	Measurements
	BG00014 BG0016 BG00212 BG0035 BG0046 BG0056 BG0067 BG0074 BG0084 BG0096 BG0106 BG0116 BG0127 BG0131 BG0140 BG0151 BG0165 BG0170 BG01896

United States

Title	Measurements
	BG0000 BG0010 BG0020 BG003

Secondary

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide in Part A.

Area under the concentration versus time curve from zero to infinity (AUC [0-∞]) of Tirzepatide in Part A.

All randomized participants in part A who received at least one dose of Tirzepatide and had evaluable PK data.

Posted

Geometric Mean

Geometric Coefficient of Variation

Hour * nanogram per milliliter (h*ng/mL)

Predose, 8hours(h), 24h,48h,72h,96h,120h,168h,336h postdose, day 29, day 43

ID	Title	Description
OG000	Part A - 0.25mg Tirzepatide	Participants received single dose of 0.25mg Tirzepatide by subcutaneous injection.
OG001	Part A - 0.5mg Tirzepatide	Participants received single dose of 0.5mg Tirzepatide by subcutaneous injection.
OG002	Part A - 1mg Tirzepatide	Participants received single dose of 1mg Tirzepatide by subcutaneous injection.
OG003	Part A - 2.5mg Tirzepatide	Participants received single dose of 2.5mg Tirzepatide by subcutaneous injection.
OG004	Part A - 5mg Tirzepatide	Participants received single dose of 5mg Tirzepatide by subcutaneous injection.
OG005	Part A - 8mg Tirzepatide	Participants received single dose of 5mg Tirzepatide by subcutaneous injection.

Units	Counts
Participants	OG0006 OG00112 OG0025 OG003

Title

Denominators

Categories

Title	Measurements
	OG0005760± 22 OG00112000± 24 OG00222600± 14 OG003

Secondary

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide in Part B

Area under the concentration versus time curve during 1 dosing interval (AUC [0-τ]) of Tirzepatide in Part B. τ equals 168 hours.

All randomized participants in part B who received at least one dose of the Tirzepatide and had evaluable PK data.

Posted

Geometric Mean

Geometric Coefficient of Variation

Hour * nanogram per milliliter (h*ng/mL)

Predose, 8hours(h), 24h,48h,72h,168h postdose

ID	Title	Description
OG000	Part B - 0.5mg Tirzepatide	Participants received 0.5mg Tirzepatide once weekly for four weeks by subcutaneous injection.
OG001	Part B - 1.5mg Tirzepatide	Participants received 1.5mg Tirzepatide once weekly for four weeks by subcutaneous injection.
OG002	Part B - 4.5mg Tirzepatide	Participants received 4.5mg Tirzepatide once weekly for four weeks by subcutaneous injection.
OG003	Part B - 5, 5, 8,10mg Tirzepatide	Participants received titrated doses of Tirzepatide once a week for four weeks by subcutaneous injection. 5mg QW followed by 5mg QW followed by 8mg QW followed by 10mg QW.

Units	Counts
Participants	OG0006 OG0016 OG0026 OG003

Title

Denominators

Categories

Title	Measurements
	OG0006000± 23 OG00116300± 13 OG00253300± 19 OG003

Secondary

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide in Part C

Area under the concentration versus time curve during 1 dosing interval (AUC [0-τ]) of Tirzepatide in Part C. τ equals 168 hours.

All randomized participants in part C who received at least one dose of Tirzepatide and had evaluable PK data.

Posted

Geometric Mean

Geometric Coefficient of Variation

Hour * nanogram per milliliter (h*ng/mL)

Predose, 8hours(h), 24h,48h,72h,168h postdose

ID	Title	Description
OG000	Part C - 0.5mg Tirzepatide	Participants received 0.5mg Tirzepatide once weekly for four weeks by subcutaneous injection.
OG001	Part C - 5mg Tirzepatide	Participants received 5mg Tirzepatide once weekly for four weeks by subcutaneous injection.
OG002	Part C - 5, 5, 10,10mg Tirzepatide	Participants received titrated doses of Tirzepatide once a week for four weeks by subcutaneous injection. 5mg QW followed by 5mg QW followed by 10mg QW followed by 10mg QW.
OG003	Part C - 5, 5, 10,15mg Tirzepatide	Participants received titrated doses of Tirzepatide once a week for four weeks by subcutaneous injection. 5mg QW followed by 5mg QW followed by 10mg QW followed by 15mg QW.

Units	Counts
Participants	OG0009 OG0018 OG00212 OG003

Title

Denominators

Categories

Title	Measurements
	OG0004770± 30 OG00150500± 20 OG00241900± 26 OG003

Secondary

Pharmacodynamics (PD): Ratio of AUC of Glucose on Day 2 to Baseline (Part C)

PD: Glucose area under the concentration versus time curve from time 0 to 2 hours (AUC[0-2h]) in Part C. Ratio to Baseline (Day -1) AUC (0-2h).

All randomized participants in part C who received at least one dose of Tirzepatide and had evaluable day 2 PD data.

Posted

Geometric Least Squares Mean

95% Confidence Interval

ratio

Pre-glucose dose, 0.5, 1, 1.5, 2 hours post-glucose dose on Day -1 and Day 2

ID	Title	Description
OG000	Part C - 0.5mg Tirzepatide	Participants received 0.5mg Tirzepatide once weekly for four weeks by subcutaneous injection.
OG001	Part C - 5mg Tirzepatide	Participants received 5mg Tirzepatide once weekly for four weeks by subcutaneous injection.
OG002	Part C - 5, 5, 10,10mg Tirzepatide	Participants received titrated doses of Tirzepatide once a week for four weeks by subcutaneous injection. 5mg QW followed by 5mg QW followed by 10mg QW followed by 10mg QW.
OG003	Part C - 5, 5, 10,15mg Tirzepatide	Participants received titrated doses of Tirzepatide once a week for four weeks by subcutaneous injection. 5mg QW followed by 5mg QW followed by 10mg QW followed by 15mg QW.

Units	Counts
Participants	OG0009 OG0019 OG00212 OG003

Title

Denominators

Categories

Title	Measurements
	OG0000.99(0.79 to 1.11) OG0010.72(0.58 to 0.81) OG0020.65(0.53 to 0.73) OG003

Secondary

Pharmacodynamics (PD): Ratio of AUC of Glucose on Day 23 to Baseline (Part C)

PD: Glucose area under the concentration versus time curve from time 0 to 2 hours (AUC[0-2h]) in Part C. Ratio to Baseline (Day -1) AUC (0-2h).

All randomized participants in part C who received at least one dose of Tirzepatide and had evaluable day 23 PD data.

Posted

Geometric Least Squares Mean

95% Confidence Interval

ratio

Pre-glucose dose, 0.5, 1, 1.5, 2 hours post-glucose dose on Day -1 and Day 23

ID	Title	Description
OG000	Part C - 0.5mg Tirzepatide	Participants received 0.5mg Tirzepatide once weekly for four weeks by subcutaneous injection.
OG001	Part C - 5mg Tirzepatide	Participants received 5mg Tirzepatide once weekly for four weeks by subcutaneous injection.
OG002	Part C - 5, 5, 10,10mg Tirzepatide	Participants received titrated doses of Tirzepatide once a week for four weeks by subcutaneous injection. 5mg QW followed by 5mg QW followed by 10mg QW followed by 10mg QW.
OG003	Part C - 5, 5, 10,15mg Tirzepatide	Participants received titrated doses of Tirzepatide once a week for four weeks by subcutaneous injection. 5mg QW followed by 5mg QW followed by 10mg QW followed by 15mg QW.

Units	Counts
Participants	OG0009 OG0017 OG00212 OG003

Title

Denominators

Categories

Title	Measurements
	OG0000.96(0.83 to 1.16) OG0010.61(0.52 to 0.75) OG0020.58(0.51 to 0.70) OG003