A Study of LY3437943 in Participants With Type 2 Diabetes | NCT04867785

ID	Type	Description	Link
J1I-MC-GZBD	Other Identifier	Eli Lilly and Company

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
0.5 milligrams (mg) LY3437943	Experimental	Participants received 0.5 mg LY3437943 administered as SC (subcutaneous) injection once weekly (QW).	Drug: LY3437943
4 mg LY3437943 (2 mg)	Experimental	Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 administered as SC injection QW.	Drug: LY3437943
4 mg LY3437943 (4 mg)	Experimental	Participants received 4 mg LY3437943 administered as SC injection QW.	Drug: LY3437943
8 mg LY3437943 (2 mg)	Experimental	Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 and then 8 mg LY3437943 administered as SC injection QW.	Drug: LY3437943
8 mg LY3437943 (4 mg)	Experimental	Participants received 4 mg LY3437943 starting dose followed by 8 mg LY3437943 administered as a SC injection QW.	Drug: LY3437943
12 mg LY3437943 (2 mg)

Name	Type	Description	Arm Group Labels	Other Names
LY3437943	Drug	Administered SC	0.5 milligrams (mg) LY3437943 12 mg LY3437943 (2 mg) 4 mg LY3437943 (2 mg) 4 mg LY3437943 (4 mg)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline in Hemoglobin A1c (HbA1c)	Change in HbA1c (%) from baseline in LY3437943 relative to placebo. 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 mixed model repeated measures (MMRM) for post-baseline measures: Variable = TreatmentTime + StrataTime + Baseline*Time.	Baseline, 24 Weeks

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline in HbA1c	Change in HbA1c (%) from baseline in LY3437943 relative to dulaglutide. LSMean was calculated using MMRM for post-baseline measures: Variable = TreatmentTime + StrataTime + Baseline*Time.	Baseline, 24 Weeks
Change From Baseline in HbA1c

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
Syed Research Consultants Llc		Sheffield	Alabama	35660	United States
San Fernando Valley Health Institute

PubMed Identifier	Type	Citation	Retractions
40609566	Derived	Coskun T, Wu Q, Schloot NC, Haupt A, Milicevic Z, Khouli C, Harris C. Effects of retatrutide on body composition in people with type 2 diabetes: a substudy of a phase 2, double-blind, parallel-group, placebo-controlled, randomised trial. Lancet Diabetes Endocrinol. 2025 Aug;13(8):674-684. doi: 10.1016/S2213-8587(25)00092-0. Epub 2025 Jun 30.
37385280

Label	URL
A Study of LY3437943 in Participants With Type 2 Diabetes	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Placebo	Participants received placebo administered as subcutaneous (SC) injection once weekly (QW).
FG001	1.5 Milligrams (mg) Dulaglutide	Participants received 1.5 mg dulaglutide administered as SC single-dose pen injection QW.

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 29, 2022	May 30, 2023

Arm/Group Information

ID	Title	Description
BG000	Placebo	Participants received placebo administered as SC injection QW.
BG001	1.5 mg Dulaglutide	Participants received 1.5 mg dulaglutide administered as SC single-dose pen injection QW.
BG002	0.5 mg LY3437943	Participants received 0.5 mg LY3437943 administered as SC injection QW.
BG003	4 mg LY3437943 (2 mg)	Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 administered as SC injection QW.
BG004	4 mg LY3437943 (4 mg)	Participants received 4 mg LY3437943 administered as SC injection QW.
BG005	8 mg LY3437943 (2 mg)	Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 and then 8 mg LY3437943 administered as SC injection QW.
BG006	8 mg LY3437943 (4 mg)	Participants received 4 mg LY3437943 starting dose followed by 8 mg LY3437943 administered as SC injection QW.
BG007	12 mg LY3437943 (2 mg)	Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943, then 8 mg LY3437943, then 12 mg LY3437943 administered as SC injection QW.
BG008	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
	BG00057.56± 10.83 BG00154.94± 10.45 BG00257.21± 9.69 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00023 BG00133 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00021 BG00120 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG00045 BG00146 BG002

Percentage of Hemoglobin A1c (HbA1c) at Baseline

HbA1c is the glycosylated fraction of hemoglobin A. 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
	BG0008.39± 1.139 BG001

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)

Change in HbA1c (%) from baseline in LY3437943 relative to placebo. 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 mixed model repeated measures (MMRM) for post-baseline measures: Variable = Treatment*Time + Strata*Time + Baseline*Time.

All randomized participants with baseline and post-baseline value at the specified time point excluding participants discontinuing study drug due to inadvertent enrollment and data after permanent discontinuation of study drug or initiation of rescue medication.

Posted

Least Squares Mean

Standard Error

percentage of HbA1c

Baseline, 24 Weeks

ID	Title	Description
OG000	Placebo	Participants received placebo administered as SC injection QW.
OG001	1.5 mg Dulaglutide	Participants received 1.5 mg dulaglutide administered as SC single-dose pen injection QW.
OG002	0.5 mg LY3437943	Participants received 0.5 mg LY3437943 administered as SC injection QW.
OG003	4 mg LY3437943 (2 mg)	Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 administered as SC injection QW.
OG004	4 mg LY3437943 (4 mg)	Participants received 4 mg LY3437943 administered as SC injection QW.
OG005	8 mg LY3437943 (2 mg)	Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 and then 8 mg LY3437943 administered as SC injection QW.
OG006	8 mg LY3437943 (4 mg)	Participants received 4 mg LY3437943 starting dose followed by 8 mg LY3437943 administered as SC injection QW.
OG007	12 mg LY3437943 (2 mg)	Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943, then 8 mg LY3437943, then 12 mg LY3437943 administered as SC injection QW.

Units	Counts
Participants	OG00045 OG00146 OG00246 OG003

Title

Denominators

Categories

Title	Measurements
	OG000-0.05± 0.21 OG001-1.41± 0.12 OG002-0.43± 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 OG002		Mixed Models Analysis		0.188		Least Squares (LS) Mean Difference	-0.38			2-Sided	95	-0.94	0.18					Superiority
OG000 OG003		Mixed Models Analysis		<0.001

Secondary

Change From Baseline in HbA1c

Change in HbA1c (%) from baseline in LY3437943 relative to dulaglutide. LSMean was calculated using MMRM for post-baseline measures: Variable = Treatment*Time + Strata*Time + Baseline*Time.

Posted

Least Squares Mean

Standard Error

percentage of HbA1c

Baseline, 24 Weeks

ID	Title	Description
OG000	Placebo	Participants received placebo administered as SC injection QW.
OG001	1.5 Milligram (mg) Dulaglutide	Participants received 1.5 mg dulaglutide administered as SC single-dose pen injection QW.
OG002	0.5 mg LY3437943	Participants received 0.5 mg LY3437943 administered as SC injection QW.
OG003	4 mg LY3437943 (2 mg)	Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 administered as SC injection QW.

Secondary

Change From Baseline in HbA1c

Change in HbA1c (%) from baseline in LY3437943 relative to placebo and dulaglutide. LSMean was calculated using MMRM for post-baseline measures: Variable = Treatment*Time + Baseline HbA1c Group (<=8.5%, >8.5%)*Time + Baseline Body Mass Index (BMI) Group (<30 kilograms/square meter (kg/m2), >=30 kg/m2)*Time + Baseline*Time.

Posted

Least Squares Mean

Standard Error

percentage of HbA1c

Baseline, 36 Weeks

ID	Title	Description
OG000	Placebo	Participants received placebo administered as SC injection QW.
OG001	1.5 Milligram (mg) Dulaglutide	Participants received 1.5 mg dulaglutide administered as SC single-dose pen injection QW.
OG002	0.5 mg LY3437943	Participants received 0.5 mg LY3437943 administered as SC injection QW.
OG003	4 mg LY3437943 (2 mg)

Secondary

Percentage of Participants Reaching HbA1c <7.0%

Percentage of participants reaching HbA1c <7.0% in LY3437943 relative to placebo and dulaglutide. Estimated percentage was determined by logistic regression model with an intercept term, treatment group, baseline BMI stratum [<30 kg/m2, ≥30 kg/m2] as fixed effects, and baseline HbA1c value as a covariate.

Posted

Number

percentage of participants

Week 24

ID	Title	Description
OG000	Placebo	Participants received placebo administered as SC injection QW.
OG001	1.5 Milligram (mg) Dulaglutide	Participants received 1.5 mg dulaglutide administered as SC single-dose pen injection QW.
OG002	0.5 mg LY3437943	Participants received 0.5 mg LY3437943 administered as SC injection QW.
OG003	4 mg LY3437943 (2 mg)

Secondary

Percentage of Participant Reaching HbA1c <7.0%

Posted

Number

percentage of participants

Week 36

ID	Title	Description
OG000	Placebo	Participants received placebo administered as SC injection QW.
OG001	1.5 Milligram (mg) Dulaglutide	Participants received 1.5 mg dulaglutide administered as SC single-dose pen injection QW.
OG002	0.5 mg LY3437943	Participants received 0.5 mg LY3437943 administered as SC injection QW.
OG003	4 mg LY3437943 (2 mg)

Secondary

Change From Baseline in Fasting Blood Glucose (FBG)

Change in FBG from baseline in LY3437943 relative to placebo and dulaglutide. LSMean was calculated using MMRM for post-baseline measures: Variable = Treatment*Time + Strata*Time + Baseline*Time.

Posted

Least Squares Mean

Standard Error

milligrams/deciliter (mg/dL)

Baseline, 24 Weeks

ID	Title	Description
OG000	Placebo	Participants received placebo administered as SC injection QW.
OG001	1.5 Milligram (mg) Dulaglutide	Participants received 1.5 mg dulaglutide administered as SC single-dose pen injection QW.
OG002	0.5 mg LY3437943	Participants received 0.5 mg LY3437943 administered as SC injection QW.
OG003	4 mg LY3437943 (2 mg)

Secondary

Change From Baseline in Fasting Blood Glucose (FBG)

Change in FBG from baseline in LY3437943 relative to placebo and dulaglutide. LSMean was calculated using MMRM for post-baseline measures: Variable = Treatment*Time + Baseline HbA1c Group (<=8.5%, >8.5%)*Time + Baseline BMI Group (<30kg/m2, >=30kg/m2)*Time + Baseline*Time.

Posted

Least Squares Mean

Standard Error

mg/dL

Baseline, 36 Weeks

ID	Title	Description
OG000	Placebo	Participants received placebo administered as SC injection QW.
OG001	1.5 Milligram (mg) Dulaglutide	Participants received 1.5 mg dulaglutide administered as SC single-dose pen injection QW.
OG002	0.5 mg LY3437943	Participants received 0.5 mg LY3437943 administered as SC injection QW.
OG003	4 mg LY3437943 (2 mg)

Secondary

Change From Baseline in Body Weight

Change in body weight from baseline in LY3437943 relative to placebo and dulaglutide. LSMean was calculated using MMRM for post-baseline measures: Variable = Treatment*Time + Strata*Time + Baseline*Time.

Posted

Least Squares Mean

Standard Error

kilograms (kg)

Baseline, 24 Weeks

ID	Title	Description
OG000	Placebo	Participants received placebo administered as SC injection QW.
OG001	1.5 Milligram (mg) Dulaglutide	Participants received 1.5 mg dulaglutide administered as SC single-dose pen injection QW.
OG002	0.5 mg LY3437943	Participants received 0.5 mg LY3437943 administered as SC injection QW.
OG003	4 mg LY3437943 (2 mg)

Secondary

Change From Baseline in Body Weight

Posted

Least Squares Mean

Standard Error

kilograms (kg)

Baseline, 36 Weeks

ID	Title	Description
OG000	Placebo	Participants received placebo administered as SC injection QW.
OG001	1.5 Milligram (mg) Dulaglutide	Participants received 1.5 mg dulaglutide administered as SC single-dose pen injection QW.
OG002	0.5 mg LY3437943	Participants received 0.5 mg LY3437943 administered as SC injection QW.
OG003	4 mg LY3437943 (2 mg)

Secondary

Population PK: Average Steady-State Plasma Concentration (Cav,ss) of LY3437943

The average steady-state plasma concentration of LY3437943 was evaluated using sparse sampling methodology/Population PK (PopPK) modeling.

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

Posted

Number

nanograms/milliliter (ng/mL)

Predose: Week 0, 1, 4, 12, 24, 30; Postdose: Week 2, 8, 16, 20, 36

ID	Title	Description
OG000	0.5 mg LY3437943	Participants received 0.5 mg LY3437943 administered as SC injection QW.
OG001	4 mg LY3437943 (2 mg)	Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 administered as SC injection QW.
OG002	4 mg LY3437943 (4 mg)	Participants received 4 mg LY3437943 administered as SC injection QW.
OG003	8 mg LY3437943 (2 mg)	Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 and then 8 mg LY3437943 administered as SC injection QW.

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Participants received placebo administered as SC injection QW.	45	3	45	15	45
EG001	1.5 Milligram (mg) Dulaglutide	Participants received 1.5 mg dulaglutide administered as SC single-dose pen injection QW.	46	1	46	24	46
EG002	0.5 mg LY3437943	Participants received 0.5 mg LY3437943 administered as SC injection QW.	47	3	47	15	47
EG003	4 mg LY3437943 (2 mg)	Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 administered as SC injection QW.	23	1	23	9	23
EG004	4 mg LY3437943 (4 mg)	Participants received 4 mg LY3437943 administered as SC injection QW.	24	2	24	17	24
EG005	8 mg LY3437943 (2 mg)	Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 and then 8 mg LY3437943 administered as SC injection QW.	26	2	26	16	26
EG006	8 mg LY3437943 (4 mg)	Participants received 4 mg LY3437943 starting dose followed by 8 mg LY3437943 administered as SC injection QW.	24	1	24	15	24
EG007	12 mg LY3437943 (2 mg)	Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943, then 8 mg LY3437943, then 12 mg LY3437943 administered as SC injection QW.	46	2	46	25	46

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Atrial fibrillation	Cardiac disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected45 at risk EG0010 events0 affected46 at risk EG0020 events0 affected47 at risk EG0030 events0 affected23 at risk EG0040 events0 affected24 at risk EG0051 events1 affected26 at risk EG0060 events0 affected24 at risk EG0070 events0 affected46 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected45 at risk EG0010 events0 affected46 at risk EG0021 events1 affected47 at risk EG003
Abdominal hernia	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected45 at risk EG0010 events0 affected46 at risk EG0020 events0 affected47 at risk EG003
Pancreatitis acute	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected45 at risk EG0010 events0 affected46 at risk EG0021 events1 affected47 at risk EG003
Cholecystitis chronic	Hepatobiliary disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected45 at risk EG0010 events0 affected46 at risk EG0020 events0 affected47 at risk EG003
Cellulitis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected45 at risk EG0010 events0 affected46 at risk EG0020 events0 affected47 at risk EG003
Osteomyelitis acute	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected45 at risk EG0010 events0 affected46 at risk EG0020 events0 affected47 at risk EG003
Fibula fracture	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected45 at risk EG0010 events0 affected46 at risk EG0021 events1 affected47 at risk EG003
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected45 at risk EG0010 events0 affected46 at risk EG0020 events0 affected47 at risk EG003
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected45 at risk EG0010 events0 affected46 at risk EG0020 events0 affected47 at risk EG003
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected45 at risk EG0010 events0 affected46 at risk EG0020 events0 affected47 at risk EG003
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected45 at risk EG0010 events0 affected46 at risk EG0020 events0 affected47 at risk EG003
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected45 at risk EG0010 events0 affected46 at risk EG0020 events0 affected47 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected45 at risk EG0010 events0 affected46 at risk EG0020 events0 affected47 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected45 at risk EG0010 events0 affected46 at risk EG0021 events1 affected47 at risk EG003
Spinal fusion surgery	Surgical and medical procedures	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected45 at risk EG0011 events1 affected46 at risk EG0020 events0 affected47 at risk EG003
Transurethral prostatectomy	Surgical and medical procedures	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected13 at risk EG0020 events0 affected24 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected45 at risk EG0010 events0 affected46 at risk EG0020 events0 affected47 at risk EG0030 events0 affected23 at risk EG0040 events0 affected24 at risk EG0050 events0 affected26 at risk EG0062 events2 affected24 at risk EG0072 events2 affected46 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected45 at risk EG0010 events0 affected46 at risk EG0020 events0 affected47 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected45 at risk EG0014 events3 affected46 at risk EG0023 events3 affected47 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected45 at risk EG0015 events4 affected46 at risk EG0022 events1 affected47 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected45 at risk EG0012 events2 affected46 at risk EG0021 events1 affected47 at risk EG003
Eructation	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected45 at risk EG0013 events2 affected46 at risk EG0021 events1 affected47 at risk EG003
Flatulence	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected45 at risk EG0012 events1 affected46 at risk EG0020 events0 affected47 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0004 events2 affected45 at risk EG00113 events8 affected46 at risk EG0022 events2 affected47 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected45 at risk EG0015 events4 affected46 at risk EG0021 events1 affected47 at risk EG003
Fatigue	General disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected45 at risk EG0010 events0 affected46 at risk EG0021 events1 affected47 at risk EG003
Covid-19	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0003 events3 affected45 at risk EG0014 events4 affected46 at risk EG0025 events5 affected47 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected45 at risk EG0013 events3 affected46 at risk EG0020 events0 affected47 at risk EG003
Sinusitis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected45 at risk EG0011 events1 affected46 at risk EG0020 events0 affected47 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0003 events2 affected45 at risk EG0011 events1 affected46 at risk EG0020 events0 affected47 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0003 events2 affected45 at risk EG0011 events1 affected46 at risk EG0020 events0 affected47 at risk EG003
Vaginal infection	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected23 at risk EG0010 events0 affected33 at risk EG0020 events0 affected23 at risk EG003
Lipase increased	Investigations	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected45 at risk EG0012 events1 affected46 at risk EG0021 events1 affected47 at risk EG003
Weight decreased	Investigations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected45 at risk EG0010 events0 affected46 at risk EG0020 events0 affected47 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected45 at risk EG0016 events6 affected46 at risk EG0022 events2 affected47 at risk EG003
Dizziness	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected45 at risk EG0011 events1 affected46 at risk EG0020 events0 affected47 at risk EG003
Headache	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected45 at risk EG0013 events3 affected46 at risk EG0022 events2 affected47 at risk EG003
Penile swelling	Reproductive system and breast disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected22 at risk EG0011 events1 affected13 at risk EG0020 events0 affected24 at risk EG003
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected23 at risk EG0010 events0 affected33 at risk EG0020 events0 affected23 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected45 at risk EG0011 events1 affected46 at risk EG0021 events1 affected47 at risk EG003

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