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A Study to Evaluate the Change in Weight After 24 Weeks Treatment With LIK066 in Obese or Overweight Adults

Primary Purpose

Obesity, Overweight

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

LIK066

Placebo

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, Overweight

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

informed consent
(BMI>=30) or (BMI>=27 with history of CV disease, hypertension, dyslipidemia, pre-diabetes or type 2 diabetes mellitus, sleep-apnea syndrome)
willing to comply with life-style intervention and treatment during the full duration of the study (approximately 54 weeks)

Exclusion Criteria:

Hypersensitivity to any of the study medications
Pregnancy or lactating women
History of malignancies
Use of pharmacologically active weight loss products
Bariatric surgery
Ketoacidosis, lactic acidosis, hyperosmolar coma in the 6 months before the screening visit.
HbA1c >10% at the screening visit.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

LIK066 2.5mg qd (Epoch 3)

Placebo (Epoch 3)

LIK066 10mg qd (Epoch 3)

LIK066 50mg qd (Epoch 3)

LIK066 150mg qd (Epoch 3)

LIK066 2.5mg bid (Epoch 3)

LIK066 5mg bid (Epoch 3)

LIK066 25mg bid (Epoch 3)

LIK066 50mg bid (Epoch 3)

LIK066 qd/LIK066 25mg qd (Epoch 4)

LIK066 bid/LIK066 35mg qd (Epoch 4)

Placebo/LIK066 25mg qd (Epoch 4)

Placebo/Placebo (Epoch 4)

Arm Description

LIK066 2.5mg qd (once daily) dosing frequency for 24 weeks.

Matching placebo tablets for 24 weeks

LIK066 10mg qd (once daily) dosing frequency for 24 weeks

LIK066 50mg qd (once daily) dosing frequency for 24 weeks

LIK066 150mg qd (once daily) dosing frequency for 24 weeks

LIK066 2.5mg bid (once daily) dosing frequency for 24 weeks

LIK066 5mg bid (once daily) dosing frequency for 24 weeks

LIK066 25mg bid (once daily) dosing frequency for 24 weeks

LIK066 50mg bid dosing frequency for 24 weeks

Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily

Outcomes

Primary Outcome Measures

Percent Change From Baseline in Body Weight at 24 Weeks

Dose-response relationship of two dose regimens of LIK066 as measured by the percent change from baseline in body weight relative to placebo after 24 weeks of treatment

Secondary Outcome Measures

Number of Subjects With Response Rate According to Percent Decrease in Body Weight for Overall Study

Responder rates according to percentage decrease in body weight either ≥ 5 % or ≥ 10 % from baseline

Number of Subjects With Response Rate According to Percent Decrease in Body Weight for Subgroups

Responder rates according to percentage decrease in body weight either ≥ 5 % or ≥ 10 % from baseline for dysglycemic, normoglycemic, Type 2 Diabetes Mellitus (T2DM)

Percentage Change From Baseline on Waist Circumference

Waist circumference will be measured to the nearest 0.1cm in a standing position, at the end of a normal expiration, using a tape at the level of the iliac crest.

Change From Baseline in Fasting Plasma Glucose (FPG) in Type 2 Diabetes Mellitus Patients (T2DM)

FPG will be measured from a blood sample obtained after an overnight fast (at least 8h after last evening food intake).

Change From Baseline in Glycated Hemoglobin A1c (HbA1c) in Type 2 Diabetes Mellitus Patients (T2DM)

HbA1c will be measured from a blood sample obtained at indicated visits and will be analyzed at a central laboratory.

Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP)

At each study visit (baseline, week 24, Week 48), after the subject has been sitting for 5 minutes with the back supported and both feet placed on the floor, SBP and DBP will be measured

Change From Baseline in 24-hour Urinary Glucose Excretion

Urinary glucose excretion will be measured from 24-hour urinary collection at indicated visits and will be analyzed at a central laboratory.

Percentage Change in Weight in the Overall Population and by Subgroups (Epoch 4)

Between -treatment analysis of percentage change from Week 24 in body weight (kg) at Week 48 (Epoch 4)

Change From Baseline to Week 24 (Epoch 3) in the 24-hour Urinary Calcium Excretion

Evaluation of 24-hour urinary calcium excretion after 24 week of treatment.

Change From Baseline Week 24 to Week 48 (Epoch 4) in the 24-hour Urinary Calcium Excretion

Evaluation of 24-hour urinary calcium after 48 weeks of treatment

Change From Baseline to Week 24 (Epoch 3) in the 24-hour Urinary Phosphorus Excretion

Evaluation of 24-hour urinary phosphorus excretion after 24 weeks of treatment

Change From Baseline Week 24 to Week 48 (Epoch 4) in the 24-hour Urinary Phosphorus Excretion

Evaluation of 24-hour urinary phosphorus excretion after 48 weeks of treatment

Change From Baseline in Fasting Lipid Profile (Lipoproteins)

Between-treatment analysis of change after 24 weeks of treatment and between Week 24 and Week 48

Change From Baseline in High Sensitive C-reactive Protein (hsCRP)

Between-treatment analysis of change after 24 weeks of treatment and between Week 24 and Week 48

Change From Baseline in Fasting Lipid Profile (Triglycerides/Cholesterol)

Between-treatment analysis of change after 24 weeks of treatment and between Week 24 and Week 48

Pharmacokinetics of LIK066: Observe Maximum Plasma Concentration (Cmax)

Observe maximum plasma concentration following administration of LIK066 (Cmax)

Pharmacokinetics of LIK066: Time to Reach the Maximum Concentration (Tmax)

Time to reach the maximum concentration after administration of LIK066 (Tmax)

Pharmacokinetics of LIK066: Area Under the Plasma Concentration-time Curve From Time Zero Time 't' (AUC0-t)

Area under the plasma concentration-time curve from time zero time 't' where t is a defined time point after administration (AUC0-t)

Pharmacokinetics of LIK066: Last Non-zero Concentration Area Under the Curve (AUClast)

Last non-zero concentration area under the curve (AUClast)

Full Information

NCT ID

NCT03100058

First Posted

March 3, 2017

Last Updated

January 27, 2020

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT03100058

Brief Title

A Study to Evaluate the Change in Weight After 24 Weeks Treatment With LIK066 in Obese or Overweight Adults

Official Title

A Randomized, Double-blind, Dose-finding Study to Evaluate the Change in Weight After 24 Weeks Treatment With 8 Doses of LIK066 Compared to Placebo in Obese or Overweight Adults, Followed by 24 Weeks Treatment With 2 Doses of LIK066 and Placebo

Study Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Completed

Study Start Date

May 6, 2017 (Actual)

Primary Completion Date

March 2, 2018 (Actual)

Study Completion Date

August 2, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This was a dose-finding study that evaluated the change in weight after 24 weeks treatment with 8 different doses of LIK066 compared to placebo in obese or overweight adults, followed by 24 weeks treatment with 2 doses of LIK066 and placebo.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity, Overweight

Keywords

Obesity, Overweight

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

460 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LIK066 2.5mg qd (Epoch 3)

Arm Type

Experimental

Arm Description

LIK066 2.5mg qd (once daily) dosing frequency for 24 weeks.

Arm Title

Placebo (Epoch 3)

Arm Type

Placebo Comparator

Arm Description

Matching placebo tablets for 24 weeks

Arm Title

LIK066 10mg qd (Epoch 3)

Arm Type

Experimental

Arm Description

LIK066 10mg qd (once daily) dosing frequency for 24 weeks

Arm Title

LIK066 50mg qd (Epoch 3)

Arm Type

Experimental

Arm Description

LIK066 50mg qd (once daily) dosing frequency for 24 weeks

Arm Title

LIK066 150mg qd (Epoch 3)

Arm Type

Experimental

Arm Description

LIK066 150mg qd (once daily) dosing frequency for 24 weeks

Arm Title

LIK066 2.5mg bid (Epoch 3)

Arm Type

Experimental

Arm Description

LIK066 2.5mg bid (once daily) dosing frequency for 24 weeks

Arm Title

LIK066 5mg bid (Epoch 3)

Arm Type

Experimental

Arm Description

LIK066 5mg bid (once daily) dosing frequency for 24 weeks

Arm Title

LIK066 25mg bid (Epoch 3)

Arm Type

Experimental

Arm Description

LIK066 25mg bid (once daily) dosing frequency for 24 weeks

Arm Title

LIK066 50mg bid (Epoch 3)

Arm Type

Experimental

Arm Description

LIK066 50mg bid dosing frequency for 24 weeks

Arm Title

LIK066 qd/LIK066 25mg qd (Epoch 4)

Arm Type

Experimental

Arm Description

Arm Title

LIK066 bid/LIK066 35mg qd (Epoch 4)

Arm Type

Experimental

Arm Description

Arm Title

Placebo/LIK066 25mg qd (Epoch 4)

Arm Type

Experimental

Arm Description

Arm Title

Placebo/Placebo (Epoch 4)

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

LIK066

Intervention Description

LIK066 will be supplied in different doses as tablets to be taken orally.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

Percent Change From Baseline in Body Weight at 24 Weeks

Description

Dose-response relationship of two dose regimens of LIK066 as measured by the percent change from baseline in body weight relative to placebo after 24 weeks of treatment

Time Frame

Baseline, Week 24 (Epoch 3)

Secondary Outcome Measure Information:

Title

Number of Subjects With Response Rate According to Percent Decrease in Body Weight for Overall Study

Description

Responder rates according to percentage decrease in body weight either ≥ 5 % or ≥ 10 % from baseline

Time Frame

Baseline, Week 24

Title

Number of Subjects With Response Rate According to Percent Decrease in Body Weight for Subgroups

Description

Responder rates according to percentage decrease in body weight either ≥ 5 % or ≥ 10 % from baseline for dysglycemic, normoglycemic, Type 2 Diabetes Mellitus (T2DM)

Time Frame

Baseline, Week 24

Title

Percentage Change From Baseline on Waist Circumference

Description

Waist circumference will be measured to the nearest 0.1cm in a standing position, at the end of a normal expiration, using a tape at the level of the iliac crest.

Time Frame

Baseline, Week 24 (Epoch 3), Week 24 to Week 48 (Epoch 4)

Title

Change From Baseline in Fasting Plasma Glucose (FPG) in Type 2 Diabetes Mellitus Patients (T2DM)

Description

FPG will be measured from a blood sample obtained after an overnight fast (at least 8h after last evening food intake).

Time Frame

Baseline, Week 24 (Epoch 3), Week 24 to Week 48 (Epoch 4)

Title

Change From Baseline in Glycated Hemoglobin A1c (HbA1c) in Type 2 Diabetes Mellitus Patients (T2DM)

Description

HbA1c will be measured from a blood sample obtained at indicated visits and will be analyzed at a central laboratory.

Time Frame

Baseline, Week 24 (Epoch 3), Week 24 to week 48 (Epoch 4)

Title

Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP)

Description

At each study visit (baseline, week 24, Week 48), after the subject has been sitting for 5 minutes with the back supported and both feet placed on the floor, SBP and DBP will be measured

Time Frame

Baseline, Week 24 (Epoch 3) Week 24 to Week 48 (Epoch 4)

Title

Change From Baseline in 24-hour Urinary Glucose Excretion

Description

Urinary glucose excretion will be measured from 24-hour urinary collection at indicated visits and will be analyzed at a central laboratory.

Time Frame

Baseline, week 24 (Epoch 3), Week 24 to Week 48 (Epoch 4)

Title

Percentage Change in Weight in the Overall Population and by Subgroups (Epoch 4)

Description

Between -treatment analysis of percentage change from Week 24 in body weight (kg) at Week 48 (Epoch 4)

Time Frame

Between Week 24 and Week 48 (Epoch 4)

Title

Change From Baseline to Week 24 (Epoch 3) in the 24-hour Urinary Calcium Excretion

Description

Evaluation of 24-hour urinary calcium excretion after 24 week of treatment.

Time Frame

Baseline, Week 24

Title

Change From Baseline Week 24 to Week 48 (Epoch 4) in the 24-hour Urinary Calcium Excretion

Description

Evaluation of 24-hour urinary calcium after 48 weeks of treatment

Time Frame

Baseline, Week 24, Week 48

Title

Change From Baseline to Week 24 (Epoch 3) in the 24-hour Urinary Phosphorus Excretion

Description

Evaluation of 24-hour urinary phosphorus excretion after 24 weeks of treatment

Time Frame

Week 24, Week 48

Title

Change From Baseline Week 24 to Week 48 (Epoch 4) in the 24-hour Urinary Phosphorus Excretion

Description

Evaluation of 24-hour urinary phosphorus excretion after 48 weeks of treatment

Time Frame

Week 24, Week 48

Title

Change From Baseline in Fasting Lipid Profile (Lipoproteins)

Description

Between-treatment analysis of change after 24 weeks of treatment and between Week 24 and Week 48

Time Frame

Baseline, Week 24, Week 24 to Week 48 (Epoch 4)

Title

Change From Baseline in High Sensitive C-reactive Protein (hsCRP)

Description

Between-treatment analysis of change after 24 weeks of treatment and between Week 24 and Week 48

Time Frame

Baseline to Week 24, Week 24 to Week 48 (Epoch 4)

Title

Change From Baseline in Fasting Lipid Profile (Triglycerides/Cholesterol)

Description

Between-treatment analysis of change after 24 weeks of treatment and between Week 24 and Week 48

Time Frame

Baseline to Week 24, Week 24 to Week 48 (Epoch 4)

Title

Pharmacokinetics of LIK066: Observe Maximum Plasma Concentration (Cmax)

Description

Observe maximum plasma concentration following administration of LIK066 (Cmax)

Time Frame

Summary at Week 24 from qd or bid regimens

Title

Pharmacokinetics of LIK066: Time to Reach the Maximum Concentration (Tmax)

Description

Time to reach the maximum concentration after administration of LIK066 (Tmax)

Time Frame

Summary at Week 24 for qd or bid regimens

Title

Pharmacokinetics of LIK066: Area Under the Plasma Concentration-time Curve From Time Zero Time 't' (AUC0-t)

Description

Area under the plasma concentration-time curve from time zero time 't' where t is a defined time point after administration (AUC0-t)

Time Frame

Summary at Week 24 from qd or bid regimens (0-6h)

Title

Pharmacokinetics of LIK066: Last Non-zero Concentration Area Under the Curve (AUClast)

Description

Last non-zero concentration area under the curve (AUClast)

Time Frame

Summary at Week 24 from qd or bid regimens

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: informed consent (BMI>=30) or (BMI>=27 with history of CV disease, hypertension, dyslipidemia, pre-diabetes or type 2 diabetes mellitus, sleep-apnea syndrome) willing to comply with life-style intervention and treatment during the full duration of the study (approximately 54 weeks) Exclusion Criteria: Hypersensitivity to any of the study medications Pregnancy or lactating women History of malignancies Use of pharmacologically active weight loss products Bariatric surgery Ketoacidosis, lactic acidosis, hyperosmolar coma in the 6 months before the screening visit. HbA1c >10% at the screening visit.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

Anniston

State/Province

Alabama

ZIP/Postal Code

36207

Country

United States

Facility Name

Novartis Investigative Site

City

Jasper

State/Province

Alabama

ZIP/Postal Code

35501

Country

United States

Facility Name

Novartis Investigative Site

City

Beverly Hills

State/Province

California

ZIP/Postal Code

90211

Country

United States

Facility Name

Novartis Investigative Site

City

Carmichael

State/Province

California

ZIP/Postal Code

95608

Country

United States

Facility Name

Novartis Investigative Site

City

Concord

State/Province

California

ZIP/Postal Code

94520

Country

United States

Facility Name

Novartis Investigative Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90017

Country

United States

Facility Name

Novartis Investigative Site

City

Northridge

State/Province

California

ZIP/Postal Code

91325

Country

United States

Facility Name

Novartis Investigative Site

City

Roseville

State/Province

California

ZIP/Postal Code

95661

Country

United States

Facility Name

Novartis Investigative Site

City

San Ramon

State/Province

California

ZIP/Postal Code

94582

Country

United States

Facility Name

Novartis Investigative Site

City

Stockton

State/Province

California

ZIP/Postal Code

95204

Country

United States

Facility Name

Novartis Investigative Site

City

Walnut Creek

State/Province

California

ZIP/Postal Code

94598

Country

United States

Facility Name

Novartis Investigative Site

City

Denver

State/Province

Colorado

ZIP/Postal Code

80246

Country

United States

Facility Name

Novartis Investigative Site

City

Golden

State/Province

Colorado

ZIP/Postal Code

80401

Country

United States

Facility Name

Novartis Investigative Site

City

Bradenton

State/Province

Florida

ZIP/Postal Code

34209

Country

United States

Facility Name

Novartis Investigative Site

City

Fort Lauderdale

State/Province

Florida

ZIP/Postal Code

33312

Country

United States

Facility Name

Novartis Investigative Site

City

Port Charlotte

State/Province

Florida

ZIP/Postal Code

33952

Country

United States

Facility Name

Novartis Investigative Site

City

West Palm Beach

State/Province

Florida

ZIP/Postal Code

33401

Country

United States

Facility Name

Novartis Investigative Site

City

Athens

State/Province

Georgia

ZIP/Postal Code

30606

Country

United States

Facility Name

Novartis Investigative Site

City

Augusta

State/Province

Georgia

ZIP/Postal Code

30909

Country

United States

Facility Name

Novartis Investigative Site

City

Honolulu

State/Province

Hawaii

ZIP/Postal Code

96814

Country

United States

Facility Name

Novartis Investigative Site

City

Gurnee

State/Province

Illinois

ZIP/Postal Code

60031

Country

United States

Facility Name

Novartis Investigative Site

City

Springfield

State/Province

Illinois

ZIP/Postal Code

62711

Country

United States

Facility Name

Novartis Investigative Site

City

Wauconda

State/Province

Illinois

ZIP/Postal Code

60084

Country

United States

Facility Name

Novartis Investigative Site

City

Evansville

State/Province

Indiana

ZIP/Postal Code

47713

Country

United States

Facility Name

Novartis Investigative Site

City

Evansville

State/Province

Indiana

ZIP/Postal Code

47714

Country

United States

Facility Name

Novartis Investigative Site

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46260

Country

United States

Facility Name

Novartis Investigative Site

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40213

Country

United States

Facility Name

Novartis Investigative Site

City

Baton Rouge

State/Province

Louisiana

ZIP/Postal Code

70808

Country

United States

Facility Name

Novartis Investigative Site

City

Covington

State/Province

Louisiana

ZIP/Postal Code

70433

Country

United States

Facility Name

Novartis Investigative Site

City

Hammond

State/Province

Louisiana

ZIP/Postal Code

70403

Country

United States

Facility Name

Novartis Investigative Site

City

Metairie

State/Province

Louisiana

ZIP/Postal Code

70006

Country

United States

Facility Name

Novartis Investigative Site

City

New Orleans

State/Province

Louisiana

ZIP/Postal Code

70115

Country

United States

Facility Name

Novartis Investigative Site

City

New Orleans

State/Province

Louisiana

ZIP/Postal Code

70119

Country

United States

Facility Name

Novartis Investigative Site

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21229

Country

United States

Facility Name

Novartis Investigative Site

City

Beltsville

State/Province

Maryland

ZIP/Postal Code

20705

Country

United States

Facility Name

Novartis Investigative Site

City

Towson

State/Province

Maryland

ZIP/Postal Code

21204

Country

United States

Facility Name

Novartis Investigative Site

City

Royal Oak

State/Province

Michigan

ZIP/Postal Code

48073

Country

United States

Facility Name

Novartis Investigative Site

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63128

Country

United States

Facility Name

Novartis Investigative Site

City

Saint Peters

State/Province

Missouri

ZIP/Postal Code

63303

Country

United States

Facility Name

Novartis Investigative Site

City

Missoula

State/Province

Montana

ZIP/Postal Code

59808

Country

United States

Facility Name

Novartis Investigative Site

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68134

Country

United States

Facility Name

Novartis Investigative Site

City

Bronx

State/Province

New York

ZIP/Postal Code

10455

Country

United States

Facility Name

Novartis Investigative Site

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

Facility Name

Novartis Investigative Site

City

New York

State/Province

New York

ZIP/Postal Code

10021

Country

United States

Facility Name

Novartis Investigative Site

City

Hickory

State/Province

North Carolina

ZIP/Postal Code

28601

Country

United States

Facility Name

Novartis Investigative Site

City

Lansdale

State/Province

Pennsylvania

ZIP/Postal Code

19446

Country

United States

Facility Name

Novartis Investigative Site

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15212

Country

United States

Facility Name

Novartis Investigative Site

City

Moncks Corner

State/Province

South Carolina

ZIP/Postal Code

29464

Country

United States

Facility Name

Novartis Investigative Site

City

Mount Pleasant

State/Province

South Carolina

ZIP/Postal Code

29464

Country

United States

Facility Name

Novartis Investigative Site

City

Summerville

State/Province

South Carolina

ZIP/Postal Code

29485

Country

United States

Facility Name

Novartis Investigative Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77081

Country

United States

Facility Name

Novartis Investigative Site

City

Bountiful

State/Province

Utah

ZIP/Postal Code

84010

Country

United States

Facility Name

Novartis Investigative Site

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84102

Country

United States

Facility Name

Novartis Investigative Site

City

Newport News

State/Province

Virginia

ZIP/Postal Code

23606

Country

United States

Facility Name

Novartis Investigative Site

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23235

Country

United States

Facility Name

Novartis Investigative Site

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23294

Country

United States

Facility Name

Novartis Investigative Site

City

Renton

State/Province

Washington

ZIP/Postal Code

98057

Country

United States

Facility Name

Novartis Investigative Site

City

Tacoma

State/Province

Washington

ZIP/Postal Code

98405

Country

United States

Facility Name

Novartis Investigative Site

City

Kenosha

State/Province

Wisconsin

ZIP/Postal Code

53144

Country

United States

Facility Name

Novartis Investigative Site

City

Graz

ZIP/Postal Code

8036

Country

Austria

Facility Name

Novartis Investigative Site

City

Wien

ZIP/Postal Code

1010

Country

Austria

Facility Name

Novartis Investigative Site

City

Wien

ZIP/Postal Code

1030

Country

Austria

Facility Name

Novartis Investigative Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4G 3E8

Country

Canada

Facility Name

Novartis Investigative Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M9W 4L6

Country

Canada

Facility Name

Novartis Investigative Site

City

Gatineau

State/Province

Quebec

ZIP/Postal Code

J8Y 6S8

Country

Canada

Facility Name

Novartis Investigative Site

City

Levis

State/Province

Quebec

ZIP/Postal Code

G6W 5M6

Country

Canada

Facility Name

Novartis Investigative Site

City

Praha 2

State/Province

Czech Republic

ZIP/Postal Code

128 08

Country

Czechia

Facility Name

Novartis Investigative Site

City

Ceske Budejovice

ZIP/Postal Code

370 01

Country

Czechia

Facility Name

Novartis Investigative Site

City

Olomouc Lazce

ZIP/Postal Code

77900

Country

Czechia

Facility Name

Novartis Investigative Site

City

Praha 1

ZIP/Postal Code

116 94

Country

Czechia

Facility Name

Novartis Investigative Site

City

Praha 3

ZIP/Postal Code

13000

Country

Czechia

Facility Name

Novartis Investigative Site

City

Slany

ZIP/Postal Code

274 01

Country

Czechia

Facility Name

Novartis Investigative Site

City

Csongrad

ZIP/Postal Code

6640

Country

Hungary

Facility Name

Novartis Investigative Site

City

Nyiregyhaza

ZIP/Postal Code

4400

Country

Hungary

Facility Name

Novartis Investigative Site

City

Szentes

ZIP/Postal Code

6600

Country

Hungary

Facility Name

Novartis Investigative Site

City

Bratislava

ZIP/Postal Code

85101

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Kosice

ZIP/Postal Code

040 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Sered

ZIP/Postal Code

92601

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Basingstoke

ZIP/Postal Code

RG24 9DT

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Blackburn

ZIP/Postal Code

BB2 1AX

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Exeter

ZIP/Postal Code

EX2 5DW

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Rotherham

ZIP/Postal Code

S65 1DA

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Stevenage

ZIP/Postal Code

SG1 4AB

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Learn more about this trial

A Study to Evaluate the Change in Weight After 24 Weeks Treatment With LIK066 in Obese or Overweight Adults

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A Study to Evaluate the Change in Weight After 24 Weeks Treatment With LIK066 in Obese or Overweight Adults

Obesity, Overweight

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial