A Dose-finding Study to Evaluate the Change in Weight Aft... | NCT03320941

Label	Type	Description	Intervention Names
LIK066 2.5 mg	Experimental	Eligible patients randomized to this arm will receive LIK066 2.5 mg orally daily for 12 weeks.	Drug: LIK066
LIK066 10 mg	Experimental	Eligible patients randomized to this arm will receive LIK066 10 mg orally daily for 12 weeks.	Drug: LIK066
LIK066 25 mg	Experimental	Eligible patients randomized to this arm will receive LIK066 25 mg orally daily for 12 weeks.	Drug: LIK066
LIK066 50 mg	Experimental	Eligible patients randomized to this arm will receive LIK066 50 mg orally daily for 12 weeks.	Drug: LIK066
Placebo	Placebo Comparator	Eligible patient randomized to this arm will receive LIK066 matching placebo orally daily for 12 weeks.	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
LIK066	Drug	LIK066 will be supplied in different doses as tablets to be taken orally daily.	LIK066 10 mg LIK066 2.5 mg LIK066 25 mg LIK066 50 mg

Measure	Description	Time Frame
Percentage Change From Baseline in Body Weight at Week 12	The dose-response relationship of LIK066 as measured by percent change from baseline in body weight relative to placebo after 12 weeks of treatment.	Baseline, Week 12

Measure	Description	Time Frame
Responder Rates According to Percentage Decrease in Body Weight From Baseline to Week 12	The responder rates according to percentage decrease in body weight either ≥ 3%, ≥ 5% or ≥ 10%, from baseline at Week 12, for the overall population and each of the subgroups (Dysglycemic and Type 2 Diabetes Mellitis (T2DM)) from Baseline to Week 12 No Statistical Analysis for >=5% and >=10% was not calculated due to division by zero

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigative Site		Matsudo	Chiba	271 0077	Japan
Novartis Investigative Site

PubMed Identifier	Type	Citation	Retractions
32072763	Derived	Yokote K, Sano M, Tsumiyama I, Keefe D. Dose-dependent reduction in body weight with LIK066 (licogliflozin) treatment in Japanese patients with obesity. Diabetes Obes Metab. 2020 Jul;22(7):1102-1110. doi: 10.1111/dom.14006. Epub 2020 Mar 12.

Label	URL
A Plain Language Trial Summary is available on novartisclinicatrials.com	View source

ID	Title	Description
FG000	LIK066 2.5mg qd	Eligible patients randomized to this arm will receive LIK066 2.5 mg orally daily (qd) for 12 weeks.
FG001	LIK066 10mg qd	Eligible patients randomized to this arm will receive LIK066 10 mg orally daily (qd) for 12 weeks.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Oct 30, 2017	Jul 23, 2019

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

Percentage Change From Baseline in Body Weight at Week 12

The dose-response relationship of LIK066 as measured by percent change from baseline in body weight relative to placebo after 12 weeks of treatment.

Full analysis set (FAS) - includes all 126 randomized participants that took at least one dose of study drug

Posted

Number

95% Confidence Interval

Percent Change

Baseline, Week 12

ID	Title	Description
OG000	LIK066 2.5mg qd	Eligible patients randomized to this arm will receive LIK066 2.5 mg orally daily (qd) for 12 weeks.
OG001	LIK066 10mg qd	Eligible patients randomized to this arm will receive LIK066 10 mg orally daily (qd) for 12 weeks.
OG002	LIK066 25 mg qd	Eligible patients randomized to this arm will receive LIK066 25 mg orally daily (qd) for 12 weeks.
OG003	LIK066 50 mg qd	Eligible patients randomized to this arm will receive LIK066 50 mg orally daily (qd) for 12 weeks.
OG004	Placebo	Eligible patient randomized to this arm will receive LIK066 matching placebo orally daily for 12 weeks.

Units	Counts
Participants	OG00019 OG00119 OG00228 OG003

Title

Denominators

Categories

Title	Measurements
	OG000-1.86(-2.59 to -0.67) OG001-2.84(-3.79 to -2.16) OG002-3.41(-3.96 to -2.84) 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 OG004						Mean Difference (Net)	-1.99			2-Sided	95	-2.92	-0.21					Other	Dose Finding
OG001 OG004

Secondary

Responder Rates According to Percentage Decrease in Body Weight From Baseline to Week 12

The responder rates according to percentage decrease in body weight either ≥ 3%, ≥ 5% or ≥ 10%, from baseline at Week 12, for the overall population and each of the subgroups (Dysglycemic and Type 2 Diabetes Mellitis (T2DM)) from Baseline to Week 12 No Statistical Analysis for >=5% and >=10% was not calculated due to division by zero

Full analysis set (FAS) - includes all 126 randomized participants that took at least one dose of study drug

Posted

Number

Percentage of Participants

Baseline, Week 12

ID	Title	Description
OG000	LIK066 2.5mg qd	Eligible patients randomized to this arm will receive LIK066 2.5 mg orally daily (qd) for 12 weeks.
OG001	LIK066 10mg qd	Eligible patients randomized to this arm will receive LIK066 10 mg orally daily (qd) for 12 weeks.
OG002	LIK066 25 mg qd	Eligible patients randomized to this arm will receive LIK066 25 mg orally daily (qd) for 12 weeks.
OG003	LIK066 50 mg qd

Secondary

Percentage Change From Baseline in Body Weight at Week 12 in Dysglycemic Participants and Participants With Type 2 Diabetes Mellitus (T2DM)

The dose-response relationship for weight loss in dysglycemic participants and participants with T2DM. Percentage change from baseline in body weight at Week 12.

Full analysis set (FAS) - includes all 126 randomized participants that took at least one dose of study (two subgroups Dysglycemic had total of 57 patients and T2DM had total of 69 patients) to equal 126

Posted

Number

95% Confidence Interval

percentage change

Baseline, Week 12

ID	Title	Description
OG000	LIK066 2.5mg qd	Eligible patients randomized to this arm will receive LIK066 2.5 mg orally daily (qd) for 12 weeks.
OG001	LIK066 10mg qd	Eligible patients randomized to this arm will receive LIK066 10 mg orally daily (qd) for 12 weeks.
OG002	LIK066 25 mg qd	Eligible patients randomized to this arm will receive LIK066 25 mg orally daily (qd) for 12 weeks.
OG003	LIK066 50 mg qd

Secondary

Change From Baseline at Week 12 on Waist Circumference at Umbilical Level

Waist circumference will be measured to the nearest 0.1 cm in a standing position, at the end of a normal expiration, using a tape at the level of umbilicus. For the overall population and each of the subgroups (Dysglycemic and Type 2 Diabetes Mellitis (T2DM)) from Baseline to Week 12

Posted

Mean

95% Confidence Interval

Baseline, Week 12

ID	Title	Description
OG000	LIK066 2.5mg qd	Eligible patients randomized to this arm will receive LIK066 2.5 mg orally daily (qd) for 12 weeks.
OG001	LIK066 10mg qd	Eligible patients randomized to this arm will receive LIK066 10 mg orally daily (qd) for 12 weeks.
OG002	LIK066 25 mg qd	Eligible patients randomized to this arm will receive LIK066 25 mg orally daily (qd) for 12 weeks.
OG003	LIK066 50 mg qd

Secondary

Percentage Change From Baseline at Week 12 on Hemoglobin A1c (HbA1c)

HbA1c will be measured from a blood sample obtained and analyzed at a central laboratory. For the overall population and each of the subgroups (Dysglycemic and Type 2 Diabetes Mellitis (T2DM)) from Baseline to Week 12

Posted

Mean

95% Confidence Interval

Percentage

Baseline, Week 12

ID	Title	Description
OG000	LIK066 2.5mg qd	Eligible patients randomized to this arm will receive LIK066 2.5 mg orally daily (qd) for 12 weeks.
OG001	LIK066 10mg qd	Eligible patients randomized to this arm will receive LIK066 10 mg orally daily (qd) for 12 weeks.
OG002	LIK066 25 mg qd	Eligible patients randomized to this arm will receive LIK066 25 mg orally daily (qd) for 12 weeks.
OG003	LIK066 50 mg qd

Secondary

Change From Baseline at Week 12 on Fasting Plasma Glucose (FPG)

FPG will be measured from a blood sample obtained after an overnight fast (at least 8h after last evening food intake) at a central laboratory. For the overall population and each of the subgroups (Dysglycemic and Type 2 Diabetes Mellitis (T2DM)) from Baseline to Week 12

Posted

Mean

95% Confidence Interval

mmol/L

Baseline, Week 12

ID	Title	Description
OG000	LIK066 2.5mg qd	Eligible patients randomized to this arm will receive LIK066 2.5 mg orally daily (qd) for 12 weeks.
OG001	LIK066 10mg qd	Eligible patients randomized to this arm will receive LIK066 10 mg orally daily (qd) for 12 weeks.
OG002	LIK066 25 mg qd	Eligible patients randomized to this arm will receive LIK066 25 mg orally daily (qd) for 12 weeks.
OG003	LIK066 50 mg qd

Secondary

Change From Baseline at Week 12 on Systolic Blood Pressure (SBP)

After the subject has been sitting for 5 minutes with the back supported and both feet placed on the floor, SBP will be measured three times using the automatic BP monitor and an appropriate size cuff. For the overall population and each of the subgroups (Dysglycemic and Type 2 Diabetes Mellitis (T2DM)) from Baseline to Week 12

Posted

Mean

95% Confidence Interval

mmHg

Baseline, Week 12

ID	Title	Description
OG000	LIK066 2.5mg qd	Eligible patients randomized to this arm will receive LIK066 2.5 mg orally daily (qd) for 12 weeks.
OG001	LIK066 10mg qd	Eligible patients randomized to this arm will receive LIK066 10 mg orally daily (qd) for 12 weeks.
OG002	LIK066 25 mg qd	Eligible patients randomized to this arm will receive LIK066 25 mg orally daily (qd) for 12 weeks.
OG003

Secondary

Change From Baseline at Week 12 on Diastolic Blood Pressure (DBP)

After the subject has been sitting for 5 minutes with the back supported and both feet placed on the floor, DBP will be measured three times using the automatic BP monitor and an appropriate size cuff. For the overall population and each of the subgroups (Dysglycemic and Type 2 Diabetes Mellitis (T2DM)) from Baseline to Week 12

Posted

Mean

95% Confidence Interval

mmHg

Baseline, Week 12

ID	Title	Description
OG000	LIK066 2.5mg qd	Eligible patients randomized to this arm will receive LIK066 2.5 mg orally daily (qd) for 12 weeks.
OG001	LIK066 10mg qd	Eligible patients randomized to this arm will receive LIK066 10 mg orally daily (qd) for 12 weeks.
OG002	LIK066 25 mg qd	Eligible patients randomized to this arm will receive LIK066 25 mg orally daily (qd) for 12 weeks.
OG003

Secondary

Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Triglycerides (TG)

Fasting lipid profile (Triglycerides (TG)), will be measured on blood samples obtained after an overnight fast and analyzed at a central laboratory For the overall population and each of the subgroups (Dysglycemic and Type 2 Diabetes Mellitis (T2DM)) from Baseline to Week 12

Posted

Mean

95% Confidence Interval

Percentage

Baseline, Week 12

ID	Title	Description
OG000	LIK066 2.5mg qd	Eligible patients randomized to this arm will receive LIK066 2.5 mg orally daily (qd) for 12 weeks.
OG001	LIK066 10mg qd	Eligible patients randomized to this arm will receive LIK066 10 mg orally daily (qd) for 12 weeks.
OG002	LIK066 25 mg qd	Eligible patients randomized to this arm will receive LIK066 25 mg orally daily (qd) for 12 weeks.
OG003	LIK066 50 mg qd

Secondary

Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Total Cholesterol

Fasting lipid profile (total cholesterol), will be measured on blood samples obtained after an overnight fast and analyzed at a central laboratory For the overall population and each of the subgroups (Dysglycemic and Type 2 Diabetes Mellitis (T2DM)) from Baseline to Week 12

Posted

Mean

95% Confidence Interval

Percentage

Baseline, Week 12

ID	Title	Description
OG000	LIK066 2.5mg qd	Eligible patients randomized to this arm will receive LIK066 2.5 mg orally daily (qd) for 12 weeks.
OG001	LIK066 10mg qd	Eligible patients randomized to this arm will receive LIK066 10 mg orally daily (qd) for 12 weeks.
OG002	LIK066 25 mg qd	Eligible patients randomized to this arm will receive LIK066 25 mg orally daily (qd) for 12 weeks.
OG003	LIK066 50 mg qd

Secondary

Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - High Density Lipoprotein (HDL)

Fasting lipid profile (HDL), will be measured on blood samples obtained after an overnight fast and analyzed at a central laboratory For the overall population and each of the subgroups (Dysglycemic and Type 2 Diabetes Mellitis (T2DM)) from Baseline to Week 12

Posted

Mean

95% Confidence Interval

Percentage

Baseline, Week 12

ID	Title	Description
OG000	LIK066 2.5mg qd	Eligible patients randomized to this arm will receive LIK066 2.5 mg orally daily (qd) for 12 weeks.
OG001	LIK066 10mg qd	Eligible patients randomized to this arm will receive LIK066 10 mg orally daily (qd) for 12 weeks.
OG002	LIK066 25 mg qd	Eligible patients randomized to this arm will receive LIK066 25 mg orally daily (qd) for 12 weeks.
OG003	LIK066 50 mg qd

Secondary

Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Low Density Lipoprotein (LDL)

Fasting lipid profile (LDL), will be measured on blood samples obtained after an overnight fast and analyzed at a central laboratory For the overall population and each of the subgroups (Dysglycemic and Type 2 Diabetes Mellitis (T2DM)) from Baseline to Week 12

Posted

Mean

95% Confidence Interval

Percentage

Baseline, Week 12

ID	Title	Description
OG000	LIK066 2.5mg qd	Eligible patients randomized to this arm will receive LIK066 2.5 mg orally daily (qd) for 12 weeks.
OG001	LIK066 10mg qd	Eligible patients randomized to this arm will receive LIK066 10 mg orally daily (qd) for 12 weeks.
OG002	LIK066 25 mg qd	Eligible patients randomized to this arm will receive LIK066 25 mg orally daily (qd) for 12 weeks.
OG003	LIK066 50 mg qd

Secondary

Percent Change From Baseline at Week 12 on High Sensitive C-reactive Protein (hsCRP)

High sensitivity CRP will be measured from a blood sample and analyzed at a central laboratory. For the overall population and each of the subgroups (Dysglycemic and Type 2 Diabetes Mellitis (T2DM)) from Baseline to Week 12

Posted

Mean

95% Confidence Interval

Percentage

Baseline, Week 12

ID	Title	Description
OG000	LIK066 2.5mg qd	Eligible patients randomized to this arm will receive LIK066 2.5 mg orally daily (qd) for 12 weeks.
OG001	LIK066 10mg qd	Eligible patients randomized to this arm will receive LIK066 10 mg orally daily (qd) for 12 weeks.
OG002	LIK066 25 mg qd	Eligible patients randomized to this arm will receive LIK066 25 mg orally daily (qd) for 12 weeks.
OG003	LIK066 50 mg qd

Secondary

Change From Baseline in Uric Acid at Week 12

Uric acid will be measured from a blood sample and analyzed at a central laboratory. For the overall population and each of the subgroups (Dysglycemic and Type 2 Diabetes Mellitis (T2DM)) from Baseline to Week 12

Posted

Mean

95% Confidence Interval

μmol/L

Baseline, Week 12

ID	Title	Description
OG000	LIK066 2.5mg qd	Eligible patients randomized to this arm will receive LIK066 2.5 mg orally daily (qd) for 12 weeks.
OG001	LIK066 10mg qd	Eligible patients randomized to this arm will receive LIK066 10 mg orally daily (qd) for 12 weeks.
OG002	LIK066 25 mg qd	Eligible patients randomized to this arm will receive LIK066 25 mg orally daily (qd) for 12 weeks.
OG003	LIK066 50 mg qd

Secondary

Change From Baseline on Urine Albumin at Week 12

Urine albumin will be measured from urine sample and analyzed at a central laboratory. For the overall population and each of the subgroups (Dysglycemic and Type 2 Diabetes Mellitis (T2DM)) from Baseline to Week 12

Posted

Mean

95% Confidence Interval

x 10^4 mmol/L

Baseline, Week 12

ID	Title	Description
OG000	LIK066 2.5mg qd	Eligible patients randomized to this arm will receive LIK066 2.5 mg orally daily (qd) for 12 weeks.
OG001	LIK066 10mg qd	Eligible patients randomized to this arm will receive LIK066 10 mg orally daily (qd) for 12 weeks.
OG002	LIK066 25 mg qd	Eligible patients randomized to this arm will receive LIK066 25 mg orally daily (qd) for 12 weeks.
OG003	LIK066 50 mg qd

Secondary

Change From Baseline on Urine Albumin to Creatinine Ratio at Week 12

Urine albumin to creatinine ratio will be measured from urine sample and analyzed at a central laboratory. For the overall population and each of the subgroups (Dysglycemic and Type 2 Diabetes Mellitis (T2DM)) from Baseline to Week 12

Posted

Mean

95% Confidence Interval

mg/mmol

Baseline, Week 12

ID	Title	Description
OG000	LIK066 2.5mg qd	Eligible patients randomized to this arm will receive LIK066 2.5 mg orally daily (qd) for 12 weeks.
OG001	LIK066 10mg qd	Eligible patients randomized to this arm will receive LIK066 10 mg orally daily (qd) for 12 weeks.
OG002	LIK066 25 mg qd	Eligible patients randomized to this arm will receive LIK066 25 mg orally daily (qd) for 12 weeks.
OG003	LIK066 50 mg qd

Secondary

Percent Change From Baseline on Visceral Fat Area (VFA) at Week 12

VFA by CT scan will be measured at visits and evaluated centrally. For the overall population and each of the subgroups (Dysglycemic and Type 2 Diabetes Mellitis (T2DM)) from Baseline to Week 12

Posted

Mean

95% Confidence Interval

Percent

Baseline, Week 12

ID	Title	Description
OG000	LIK066 2.5mg qd	Eligible patients randomized to this arm will receive LIK066 2.5 mg orally daily (qd) for 12 weeks.
OG001	LIK066 10mg qd	Eligible patients randomized to this arm will receive LIK066 10 mg orally daily (qd) for 12 weeks.
OG002	LIK066 25 mg qd	Eligible patients randomized to this arm will receive LIK066 25 mg orally daily (qd) for 12 weeks.
OG003	LIK066 50 mg qd

Secondary

Percent Change From Baseline on Subcutaneous Fat Area (SFA) at Week 12

SFA by CT scan will be measured at visits and evaluated centrally. For the overall population and each of the subgroups (Dysglycemic and Type 2 Diabetes Mellitis (T2DM)) from Baseline to Week 12

Posted

Mean

95% Confidence Interval

Percentage

Baseline, Week 12

ID	Title	Description
OG000	LIK066 2.5mg qd	Eligible patients randomized to this arm will receive LIK066 2.5 mg orally daily (qd) for 12 weeks.
OG001	LIK066 10mg qd	Eligible patients randomized to this arm will receive LIK066 10 mg orally daily (qd) for 12 weeks.
OG002	LIK066 25 mg qd	Eligible patients randomized to this arm will receive LIK066 25 mg orally daily (qd) for 12 weeks.
OG003	LIK066 50 mg qd

Secondary

Pharmacokinetics - Plasma Trough Concentrations of LIK066

Plasma trough concentrations of LIK066 were measured at Week 12 after daily administrations of LIK066 (2.5, 10, 25 and 50 mg).

Safety set (SAF): the SAF includes all participants who received at least one dose of study medication.

Posted

Mean

Standard Deviation

ng/mL

Week 12

ID	Title	Description
OG000	LIK066 2.5mg qd	Eligible patients randomized to this arm will receive LIK066 2.5 mg orally daily (qd) for 12 weeks.
OG001	LIK066 10mg qd	Eligible patients randomized to this arm will receive LIK066 10 mg orally daily (qd) for 12 weeks.
OG002	LIK066 25 mg qd	Eligible patients randomized to this arm will receive LIK066 25 mg orally daily (qd) for 12 weeks.
OG003	LIK066 50 mg qd	Eligible patients randomized to this arm will receive LIK066 50 mg orally daily (qd) for 12 weeks.

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Vertigo	Ear and labyrinth disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected19 at risk EG0011 affected19 at risk EG0020 affected28 at risk EG0030 affected31 at risk EG0040 affected29 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected19 at risk EG0010 affected19 at risk EG0024 affected28 at risk EG003
Flatulence	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected19 at risk EG0010 affected19 at risk EG0020 affected28 at risk EG003
Gastric polyps	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected19 at risk EG0011 affected19 at risk EG0021 affected28 at risk EG003
Gastritis erosive	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected19 at risk EG0010 affected19 at risk EG0020 affected28 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected19 at risk EG0010 affected19 at risk EG0022 affected28 at risk EG003
Large intestine polyp	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected19 at risk EG0011 affected19 at risk EG0020 affected28 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected19 at risk EG0011 affected19 at risk EG0020 affected28 at risk EG003
Malaise	General disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected19 at risk EG0011 affected19 at risk EG0020 affected28 at risk EG003
Hepatic steatosis	Hepatobiliary disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected19 at risk EG0010 affected19 at risk EG0020 affected28 at risk EG003
Asymptomatic bacteriuria	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0000 affected19 at risk EG0011 affected19 at risk EG0020 affected28 at risk EG003
Bronchitis	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0001 affected19 at risk EG0010 affected19 at risk EG0021 affected28 at risk EG003
Cellulitis	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0000 affected19 at risk EG0011 affected19 at risk EG0020 affected28 at risk EG003
Conjunctivitis	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0000 affected19 at risk EG0011 affected19 at risk EG0020 affected28 at risk EG003
Gingivitis	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0001 affected19 at risk EG0010 affected19 at risk EG0020 affected28 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0002 affected19 at risk EG0013 affected19 at risk EG0025 affected28 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0000 affected19 at risk EG0011 affected19 at risk EG0020 affected28 at risk EG003
Post-traumatic neck syndrome	Injury, poisoning and procedural complications	MedDRA (21.0)	Systematic Assessment	EG0001 affected19 at risk EG0010 affected19 at risk EG0020 affected28 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA (21.0)	Systematic Assessment	EG0001 affected19 at risk EG0010 affected19 at risk EG0020 affected28 at risk EG003
Protein urine present	Investigations	MedDRA (21.0)	Systematic Assessment	EG0001 affected19 at risk EG0010 affected19 at risk EG0022 affected28 at risk EG003
Urine albumin/creatinine ratio increased	Investigations	MedDRA (21.0)	Systematic Assessment	EG0000 affected19 at risk EG0012 affected19 at risk EG0020 affected28 at risk EG003
White blood cells urine positive	Investigations	MedDRA (21.0)	Systematic Assessment	EG0001 affected19 at risk EG0010 affected19 at risk EG0020 affected28 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected19 at risk EG0011 affected19 at risk EG0022 affected28 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected19 at risk EG0011 affected19 at risk EG0020 affected28 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected19 at risk EG0011 affected19 at risk EG0020 affected28 at risk EG003
Periarthritis	Musculoskeletal and connective tissue disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected19 at risk EG0010 affected19 at risk EG0020 affected28 at risk EG003
Headache	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected19 at risk EG0010 affected19 at risk EG0020 affected28 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected19 at risk EG0011 affected19 at risk EG0020 affected28 at risk EG003
Pollakiuria	Renal and urinary disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected19 at risk EG0010 affected19 at risk EG0020 affected28 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected19 at risk EG0010 affected19 at risk EG0020 affected28 at risk EG003
Eczema	Skin and subcutaneous tissue disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected19 at risk EG0010 affected19 at risk EG0020 affected28 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected19 at risk EG0011 affected19 at risk EG0020 affected28 at risk EG003

ID	Term
D009765	Obesity
D015431	Weight Loss

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D001835	Body Weight
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D001836	Body Weight Changes

ID	Title	Description
BG000	LIK066 2.5mg qd	Eligible patients randomized to this arm will receive LIK066 2.5 mg orally daily (qd) for 12 weeks.
BG001	LIK066 10mg qd	Eligible patients randomized to this arm will receive LIK066 10 mg orally daily (qd) for 12 weeks.
BG002	LIK066 25 mg qd	Eligible patients randomized to this arm will receive LIK066 25 mg orally daily (qd) for 12 weeks.
BG003	LIK066 50 mg qd	Eligible patients randomized to this arm will receive LIK066 50 mg orally daily (qd) for 12 weeks.
BG004	Placebo	Eligible patient randomized to this arm will receive LIK066 matching placebo orally daily for 12 weeks.
BG005	Total	Total of all reporting groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	LIK066 2.5mg qd	Eligible patients randomized to this arm will receive LIK066 2.5 mg orally daily (qd) for 12 weeks.	19	0	19	10	19
EG001	LIK066 10mg qd	Eligible patients randomized to this arm will receive LIK066 10 mg orally daily (qd) for 12 weeks.	19	0	19	12	19
EG002	LIK066 25mg qd	Eligible patients randomized to this arm will receive LIK066 25 mg orally daily (qd) for 12 weeks.	28	0	28	13	28
EG003	LIK066 50mg qd	Eligible patients randomized to this arm will receive LIK066 50 mg orally daily (qd) for 12 weeks.	31	1	31	20	31
EG004	Placebo	Eligible patient randomized to this arm will receive LIK066 matching placebo orally daily for 12 weeks.	29	0	29	9	29