A Study of Tirzepatide (LY3298176) in Chinese Participant... | NCT05963022

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

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
5 Milligram (mg) Tirzepatide	Experimental	Participants received 5 mg of tirzepatide administered as subcutaneous (SC) injection via a single-dose pen (SDP) once weekly (QW) for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached.	Drug: Tirzepatide
10 mg Tirzepatide	Experimental	Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached.	Drug: Tirzepatide
15 mg Tirzepatide	Experimental	Participants received 15 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until the maintenance dose of 15 mg was reached.	Drug: Tirzepatide
Placebo	Placebo Comparator	Participants received tirzepatide matched placebo administered as SC injection via a SDP QW for 40 weeks.	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Tirzepatide	Drug	Administered SC	10 mg Tirzepatide 15 mg Tirzepatide 5 Milligram (mg) Tirzepatide

Measure	Description	Time Frame
Change From Baseline in Hemoglobin A1c (HbA1c)	HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least squares (LS) mean was calculated using ANCOVA model with Baseline + Prior Antihyperglycemic Use + Treatment (Type III sum of squares) as variables.	Baseline, Week 40

Measure	Description	Time Frame
Percentage of Participants With HbA1c Target Values of <7.0% (<53 Millimole/Mole [mmol/Mol])	HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100. Percentage of participants with HbA1c <7.0% (<53 mmol/mol) is reported here.

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
Chinese PLA General Hospital		Beijing	Beijing Municipality	100853	China
Shunde Hospital of Southern Medical Univesity

PubMed Identifier	Type	Citation	Retractions
42296968	Derived	Yin Y, Ma J, Liu D, Duan W, Cheng Z, Jiang H, Zhang Y, Wu G, Zhuang H, Gu W, Mu Y. Tirzepatide monotherapy in Chinese patients with early type 2 diabetes: A randomized, double-blind, placebo-controlled phase 3 trial (SURPASS-CN-MONO). Med. 2026 Jun 15:101183. doi: 10.1016/j.medj.2026.101183. Online ahead of print.

ID	Title	Description
FG000	5 Milligram (mg) Tirzepatide	Participants received 5 mg of tirzepatide administered as subcutaneous (SC) injection via a single-dose pen (SDP) once weekly (QW) for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached.
FG001

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Dec 5, 2023	Sep 10, 2025

Arm/Group Information

ID	Title	Description
BG000	5 mg Tirzepatide	Participants received 5 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached
BG001	10 mg Tirzepatide	Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached.
BG002	15 mg Tirzepatide	Participants received 15 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until the maintenance dose of 15 mg was reached.
BG003	Placebo	Participants received tirzepatide matched placebo administered as SC injection via a SDP QW for 40 weeks.
BG004	Total	Total of all reporting groups

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 Hemoglobin A1c (HbA1c)

HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least squares (LS) mean was calculated using ANCOVA model with Baseline + Prior Antihyperglycemic Use + Treatment (Type III sum of squares) as variables.

All randomized participants who received at least one dose of study drug with baseline and post-baseline value at the specified time point for this outcome, regardless of adherence to study intervention or initiation of rescue antihyperglycemic medication.

Posted

Least Squares Mean

Standard Error

percentage of HbA1c

Baseline, Week 40

ID	Title	Description
OG000	5 mg Tirzepatide	Participants received 5 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached
OG001	10 mg Tirzepatide	Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached.
OG002	15 mg Tirzepatide	Participants received 15 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until the maintenance dose of 15 mg was reached.
OG003	Placebo	Participants received tirzepatide matched placebo administered as SC injection via a SDP QW for 40 weeks.

Units	Counts
Participants	OG00052 OG00144 OG00248 OG003

Title

Denominators

Categories

Title	Measurements
	OG000-2.19± 0.121 OG001-1.75± 0.131 OG002-2.03± 0.124 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 OG003		ANCOVA		<0.001		LS Mean Difference	-1.42			2-Sided	95	-1.76	-1.07					Superiority
OG001 OG003		ANCOVA		<0.001

Secondary

Percentage of Participants With HbA1c Target Values of <7.0% (<53 Millimole/Mole [mmol/Mol])

HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100. Percentage of participants with HbA1c <7.0% (<53 mmol/mol) is reported here.

All randomized participants who received at least one dose of study drug and had evaluable data for this outcome.

Posted

Number

percentage of participants

Week 40

ID	Title	Description
OG000	5 mg Tirzepatide	Participants received 5 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached
OG001	10 mg Tirzepatide	Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached.
OG002	15 mg Tirzepatide

Secondary

Change From Baseline in Fasting Serum Glucose

LS mean was calculated using ANCOVA model with Baseline + Prior Antihyperglycemic Use + Baseline HbA1c Group (<=8.5%, >8.5%) + Treatment (Type III sum of squares) as variables.

Posted

Least Squares Mean

Standard Error

milligram per deciliter (mg/dL)

Baseline, Week 40

ID	Title	Description
OG000	5 mg Tirzepatide	Participants received 5 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached
OG001	10 mg Tirzepatide	Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached.
OG002	15 mg Tirzepatide	Participants received 15 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until the maintenance dose of 15 mg was reached.

Secondary

Percentage of Participants With HbA1c Target Values of ≤6.5% (≤48 mmol/Mol)

All randomized participants who received at least one dose of study drug and had evaluable data for this outcome.

Posted

Number

percentage of participants

Week 40

ID	Title	Description
OG000	5 mg Tirzepatide	Participants received 5 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached
OG001	10 mg Tirzepatide	Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached.
OG002	15 mg Tirzepatide

Secondary

Change From Baseline in Body Weight

LS mean was calculated using ANCOVA model with Baseline + Prior Antihyperglycemic Use + Baseline HbA1c Group (<=8.5%, >8.5%) + Treatment (Type III sum of squares) as variables.

Posted

Least Squares Mean

Standard Error

kilograms (kg)

Baseline, Week 40

ID	Title	Description
OG000	5 mg Tirzepatide	Participants received 5 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached
OG001	10 mg Tirzepatide	Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached.
OG002	15 mg Tirzepatide	Participants received 15 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until the maintenance dose of 15 mg was reached.

Secondary

Percentage of Participants With HbA1c Target Values of <5.7% (<39 mmol/Mol)

All randomized participants who received at least one dose of study drug and had evaluable data for this outcome.

Posted

Number

percentage of participants

Week 40

ID	Title	Description
OG000	5 mg Tirzepatide	Participants received 5 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached
OG001	10 mg Tirzepatide	Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached.
OG002	15 mg Tirzepatide

Secondary

Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose Profiles (SMBG)

The SMBG data were collected at the following 7 time points: Morning Premeal - Fasting, Morning 2-hour Post meal, Midday Premeal, Midday 2-hour Post meal, Evening Premeal, Evening 2-hour Post meal and Bedtime. The daily average was calculated as the average of the 7 blood glucose values collected on a particular day. LS Mean was calculated using mixed model repeated measures (MMRM) for post-baseline measures: Variable = Baseline + Baseline HbA1c (<=8.5%, >8.5%) + Prior Antihyperglycemic Use + Treatment + Time + Treatment*Time(Type III sum of squares). Variance-Covariance structure (Change from Baseline) = Unstructured.

All randomized participants who received at least one dose of study drug with baseline and post-baseline value at the specified time point for this outcome regardless of adherence to study drug or initiation of rescue antihyperglycemic medication.

Posted

Least Squares Mean

Standard Error

milligram per deciliter (mg/dL)

Baseline, Week 40

ID	Title	Description
OG000	5 mg Tirzepatide	Participants received 5 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached
OG001	10 mg Tirzepatide	Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached.

Secondary

Percentage of Participants Who Achieved Weight Loss of ≥5%

Percentage of Participants who Achieved Weight Loss ≥5% is reported here.

All randomized participants who received at least one dose of study drug and had evaluable data for this outcome.

Posted

Number

percentage of participants

Week 40

ID	Title	Description
OG000	5 mg Tirzepatide	Participants received 5 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached
OG001	10 mg Tirzepatide	Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached.
OG002	15 mg Tirzepatide	Participants received 15 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until the maintenance dose of 15 mg was reached.

Secondary

Percentage of Participants Who Achieved Weight Loss of ≥10%

Percentage of Participants who Achieved Weight Loss ≥10% is reported here.

All randomized participants who received at least one dose of study drug and had evaluable data for this outcome.

Posted

Number

percentage of participants

Week 40

ID	Title	Description
OG000	5 mg Tirzepatide	Participants received 5 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached
OG001	10 mg Tirzepatide	Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached.
OG002	15 mg Tirzepatide	Participants received 15 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until the maintenance dose of 15 mg was reached.

Secondary

Percentage of Participants Who Achieved Weight Loss of ≥15%

Percentage of Participants who Achieved Weight Loss ≥15% is reported here.

All randomized participants who received at least one dose of study drug and had evaluable data for this outcome.

Posted

Number

percentage of participants

Week 40

ID	Title	Description
OG000	5 mg Tirzepatide	Participants received 5 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached
OG001	10 mg Tirzepatide	Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached.
OG002	15 mg Tirzepatide	Participants received 15 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until the maintenance dose of 15 mg was reached.

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	5 mg Tirzepatide	Participants received 5 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached.	52	5	52	41	52
EG001	10 mg Tirzepatide	Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached.	51	6	51	44	51
EG002	15 mg Tirzepatide	Participants received 15 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until the maintenance dose of 15 mg was reached.	52	3	52	45	52
EG003	Placebo	Participants received tirzepatide matched placebo administered as SC injection via a SDP QW for 40 weeks.	51	5	51	36	51

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Angina unstable	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected52 at risk EG0011 events1 affected51 at risk EG0020 events0 affected52 at risk EG0030 events0 affected51 at risk
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected52 at risk EG0010 events0 affected51 at risk EG0020 events0 affected52 at risk EG003
Cataract	Eye disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected52 at risk EG0010 events0 affected51 at risk EG0020 events0 affected52 at risk EG003
Optic ischaemic neuropathy	Eye disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected52 at risk EG0011 events1 affected51 at risk EG0020 events0 affected52 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected52 at risk EG0010 events0 affected51 at risk EG0020 events0 affected52 at risk EG003
Large intestine polyp	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected52 at risk EG0011 events1 affected51 at risk EG0021 events1 affected52 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected52 at risk EG0010 events0 affected51 at risk EG0020 events0 affected52 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected52 at risk EG0010 events0 affected51 at risk EG0020 events0 affected52 at risk EG003
Appendicitis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected52 at risk EG0010 events0 affected51 at risk EG0021 events1 affected52 at risk EG003
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected52 at risk EG0011 events1 affected51 at risk EG0020 events0 affected52 at risk EG003
Fracture	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected52 at risk EG0010 events0 affected51 at risk EG0020 events0 affected52 at risk EG003
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected52 at risk EG0010 events0 affected51 at risk EG0020 events0 affected52 at risk EG003
Papillary thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected52 at risk EG0010 events0 affected51 at risk EG0021 events1 affected52 at risk EG003
Cerebral infarction	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected52 at risk EG0011 events1 affected51 at risk EG0020 events0 affected52 at risk EG003
Myasthenia gravis	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected52 at risk EG0010 events0 affected51 at risk EG0020 events0 affected52 at risk EG003
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected23 at risk EG0011 events1 affected20 at risk EG0020 events0 affected25 at risk EG003
Nephrotic syndrome	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected52 at risk EG0011 events1 affected51 at risk EG0020 events0 affected52 at risk EG003
Ureterolithiasis	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected52 at risk EG0010 events0 affected51 at risk EG0021 events1 affected52 at risk EG003
Postmenopausal haemorrhage	Reproductive system and breast disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected23 at risk EG0010 events0 affected20 at risk EG0020 events0 affected25 at risk EG003
Nasal cavity mass	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected52 at risk EG0010 events0 affected51 at risk EG0020 events0 affected52 at risk EG003
Hypertension	Vascular disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected52 at risk EG0010 events0 affected51 at risk EG0020 events0 affected52 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Atrioventricular block first degree	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected52 at risk EG0013 events3 affected51 at risk EG0020 events0 affected52 at risk EG0030 events0 affected51 at risk
Tachycardia	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected52 at risk EG0014 events3 affected51 at risk EG0020 events0 affected52 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG00016 events8 affected52 at risk EG0019 events6 affected51 at risk EG0026 events6 affected52 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0003 events3 affected52 at risk EG0012 events2 affected51 at risk EG0021 events1 affected52 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0004 events4 affected52 at risk EG0015 events4 affected51 at risk EG0023 events3 affected52 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG00019 events12 affected52 at risk EG00121 events12 affected51 at risk EG00241 events15 affected52 at risk EG003
Eructation	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0002 events1 affected52 at risk EG00113 events4 affected51 at risk EG00221 events3 affected52 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0009 events5 affected52 at risk EG00119 events11 affected51 at risk EG00234 events14 affected52 at risk EG003
Regurgitation	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0004 events3 affected52 at risk EG0014 events3 affected51 at risk EG0026 events5 affected52 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0003 events3 affected52 at risk EG0015 events4 affected51 at risk EG00217 events10 affected52 at risk EG003
Fatigue	General disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected52 at risk EG0016 events2 affected51 at risk EG0023 events3 affected52 at risk EG003
Injection site reaction	General disorders	MedDRA 27.0	Systematic Assessment	EG0007 events2 affected52 at risk EG00132 events2 affected51 at risk EG00227 events5 affected52 at risk EG003
Pyrexia	General disorders	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected52 at risk EG0010 events0 affected51 at risk EG0023 events3 affected52 at risk EG003
Conjunctivitis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected52 at risk EG0013 events3 affected51 at risk EG0020 events0 affected52 at risk EG003
Influenza	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected52 at risk EG0014 events3 affected51 at risk EG0021 events1 affected52 at risk EG003
Respiratory tract infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0006 events5 affected52 at risk EG0011 events1 affected51 at risk EG0021 events1 affected52 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG00014 events11 affected52 at risk EG00112 events9 affected51 at risk EG00213 events9 affected52 at risk EG003
Vaginal infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected23 at risk EG0011 events1 affected20 at risk EG0020 events0 affected25 at risk EG003
Amylase increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected52 at risk EG0012 events2 affected51 at risk EG0026 events5 affected52 at risk EG003
Lipase increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0004 events4 affected52 at risk EG0014 events2 affected51 at risk EG0024 events4 affected52 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG00018 events15 affected52 at risk EG00121 events13 affected51 at risk EG00219 events14 affected52 at risk EG003
Dyslipidaemia	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected52 at risk EG0012 events2 affected51 at risk EG0022 events2 affected52 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0002 events1 affected52 at risk EG0010 events0 affected51 at risk EG0022 events2 affected52 at risk EG003
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected52 at risk EG0014 events4 affected51 at risk EG0020 events0 affected52 at risk EG003
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0005 events5 affected52 at risk EG0013 events3 affected51 at risk EG0024 events4 affected52 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected52 at risk EG0013 events3 affected51 at risk EG0021 events1 affected52 at risk EG003
Dizziness	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0002 events1 affected52 at risk EG0011 events1 affected51 at risk EG0023 events3 affected52 at risk EG003
Hypoaesthesia	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected52 at risk EG0016 events4 affected51 at risk EG0020 events0 affected52 at risk EG003
Endometrial hyperplasia	Reproductive system and breast disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected23 at risk EG0011 events1 affected20 at risk EG0020 events0 affected25 at risk EG003
Menopausal symptoms	Reproductive system and breast disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected23 at risk EG0011 events1 affected20 at risk EG0020 events0 affected25 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0003 events3 affected52 at risk EG0010 events0 affected51 at risk EG0023 events3 affected52 at risk EG003
Hypertension	Vascular disorders	MedDRA 27.0	Systematic Assessment	EG0003 events3 affected52 at risk EG0014 events4 affected51 at risk EG0020 events0 affected52 at risk EG003
Hypotension	Vascular disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected52 at risk EG0010 events0 affected51 at risk EG0024 events3 affected52 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