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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03100058
• Other study ID #: CLIK066B2201
• Secondary ID: 2016-002868-14
• Status: Completed
• Phase: Phase 2
• Start date: May 6, 2017
• Est. completion date: August 2, 2018

Study information

• Verified date: January 2020
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 460
• Est. completion date: August 2, 2018
• Est. primary completion date: March 2, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. informed consent

2. (BMI>=30) or (BMI>=27 with history of CV disease, hypertension, dyslipidemia, pre-diabetes or type 2 diabetes mellitus, sleep-apnea syndrome)

3. 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.

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Drug:
• LIK066
LIK066 will be supplied in different doses as tablets to be taken orally.
• Placebo
Placebo

Locations

Country	Name	City	State
Austria	Novartis Investigative Site	Graz
Austria	Novartis Investigative Site	Wien
Austria	Novartis Investigative Site	Wien
Canada	Novartis Investigative Site	Gatineau	Quebec
Canada	Novartis Investigative Site	Levis	Quebec
Canada	Novartis Investigative Site	Toronto	Ontario
Canada	Novartis Investigative Site	Toronto	Ontario
Czechia	Novartis Investigative Site	Ceske Budejovice
Czechia	Novartis Investigative Site	Olomouc Lazce
Czechia	Novartis Investigative Site	Praha 1
Czechia	Novartis Investigative Site	Praha 2	Czech Republic
Czechia	Novartis Investigative Site	Praha 3
Czechia	Novartis Investigative Site	Slany
Hungary	Novartis Investigative Site	Csongrad
Hungary	Novartis Investigative Site	Nyiregyhaza
Hungary	Novartis Investigative Site	Szentes
Slovakia	Novartis Investigative Site	Bratislava
Slovakia	Novartis Investigative Site	Kosice
Slovakia	Novartis Investigative Site	Sered
United Kingdom	Novartis Investigative Site	Basingstoke
United Kingdom	Novartis Investigative Site	Blackburn
United Kingdom	Novartis Investigative Site	Exeter
United Kingdom	Novartis Investigative Site	Rotherham
United Kingdom	Novartis Investigative Site	Stevenage
United States	Novartis Investigative Site	Anniston	Alabama
United States	Novartis Investigative Site	Athens	Georgia
United States	Novartis Investigative Site	Augusta	Georgia
United States	Novartis Investigative Site	Baltimore	Maryland
United States	Novartis Investigative Site	Baton Rouge	Louisiana
United States	Novartis Investigative Site	Beltsville	Maryland
United States	Novartis Investigative Site	Beverly Hills	California
United States	Novartis Investigative Site	Bountiful	Utah
United States	Novartis Investigative Site	Bradenton	Florida
United States	Novartis Investigative Site	Bronx	New York
United States	Novartis Investigative Site	Carmichael	California
United States	Novartis Investigative Site	Concord	California
United States	Novartis Investigative Site	Covington	Louisiana
United States	Novartis Investigative Site	Denver	Colorado
United States	Novartis Investigative Site	Evansville	Indiana
United States	Novartis Investigative Site	Evansville	Indiana
United States	Novartis Investigative Site	Fort Lauderdale	Florida
United States	Novartis Investigative Site	Golden	Colorado
United States	Novartis Investigative Site	Gurnee	Illinois
United States	Novartis Investigative Site	Hammond	Louisiana
United States	Novartis Investigative Site	Hickory	North Carolina
United States	Novartis Investigative Site	Honolulu	Hawaii
United States	Novartis Investigative Site	Houston	Texas
United States	Novartis Investigative Site	Indianapolis	Indiana
United States	Novartis Investigative Site	Jasper	Alabama
United States	Novartis Investigative Site	Kenosha	Wisconsin
United States	Novartis Investigative Site	Lansdale	Pennsylvania
United States	Novartis Investigative Site	Los Angeles	California
United States	Novartis Investigative Site	Louisville	Kentucky
United States	Novartis Investigative Site	Metairie	Louisiana
United States	Novartis Investigative Site	Missoula	Montana
United States	Novartis Investigative Site	Moncks Corner	South Carolina
United States	Novartis Investigative Site	Mount Pleasant	South Carolina
United States	Novartis Investigative Site	New Orleans	Louisiana
United States	Novartis Investigative Site	New Orleans	Louisiana
United States	Novartis Investigative Site	New York	New York
United States	Novartis Investigative Site	New York	New York
United States	Novartis Investigative Site	Newport News	Virginia
United States	Novartis Investigative Site	Northridge	California
United States	Novartis Investigative Site	Omaha	Nebraska
United States	Novartis Investigative Site	Pittsburgh	Pennsylvania
United States	Novartis Investigative Site	Port Charlotte	Florida
United States	Novartis Investigative Site	Renton	Washington
United States	Novartis Investigative Site	Richmond	Virginia
United States	Novartis Investigative Site	Richmond	Virginia
United States	Novartis Investigative Site	Roseville	California
United States	Novartis Investigative Site	Royal Oak	Michigan
United States	Novartis Investigative Site	Saint Louis	Missouri
United States	Novartis Investigative Site	Saint Peters	Missouri
United States	Novartis Investigative Site	Salt Lake City	Utah
United States	Novartis Investigative Site	San Ramon	California
United States	Novartis Investigative Site	Springfield	Illinois
United States	Novartis Investigative Site	Stockton	California
United States	Novartis Investigative Site	Summerville	South Carolina
United States	Novartis Investigative Site	Tacoma	Washington
United States	Novartis Investigative Site	Towson	Maryland
United States	Novartis Investigative Site	Walnut Creek	California
United States	Novartis Investigative Site	Wauconda	Illinois
United States	Novartis Investigative Site	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Austria,  Canada,  Czechia,  Hungary,  Slovakia,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline, Week 24 (Epoch 3)
Secondary	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	Baseline, Week 24
Secondary	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)	Baseline, Week 24
Secondary	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.	Baseline, Week 24 (Epoch 3), Week 24 to Week 48 (Epoch 4)
Secondary	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).	Baseline, Week 24 (Epoch 3), Week 24 to Week 48 (Epoch 4)
Secondary	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.	Baseline, Week 24 (Epoch 3), Week 24 to week 48 (Epoch 4)
Secondary	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	Baseline, Week 24 (Epoch 3) Week 24 to Week 48 (Epoch 4)
Secondary	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.	Baseline, week 24 (Epoch 3), Week 24 to Week 48 (Epoch 4)
Secondary	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)	Between Week 24 and Week 48 (Epoch 4)
Secondary	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.	Baseline, Week 24
Secondary	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	Baseline, Week 24, Week 48
Secondary	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	Week 24, Week 48
Secondary	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	Week 24, Week 48
Secondary	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	Baseline, Week 24, Week 24 to Week 48 (Epoch 4)
Secondary	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	Baseline to Week 24, Week 24 to Week 48 (Epoch 4)
Secondary	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	Baseline to Week 24, Week 24 to Week 48 (Epoch 4)
Secondary	Pharmacokinetics of LIK066: Observe Maximum Plasma Concentration (Cmax)	Observe maximum plasma concentration following administration of LIK066 (Cmax)	Summary at Week 24 from qd or bid regimens
Secondary	Pharmacokinetics of LIK066: Time to Reach the Maximum Concentration (Tmax)	Time to reach the maximum concentration after administration of LIK066 (Tmax)	Summary at Week 24 for qd or bid regimens
Secondary	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)	Summary at Week 24 from qd or bid regimens (0-6h)
Secondary	Pharmacokinetics of LIK066: Last Non-zero Concentration Area Under the Curve (AUClast)	Last non-zero concentration area under the curve (AUClast)	Summary at Week 24 from qd or bid regimens