Clinical trial NCT03100058: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obesity
Overweight
Keywords: Obesity
Overweight
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2017-04-04
Enrollment: 460
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percent Change From Baseline in Body Weight at 24 Weeks
timeFrame: Baseline, Week 24 (Epoch 3)
Secondary outcomes:
measure: Number of Subjects With Response Rate According to Percent Decrease in Body Weight for Overall Study
timeFrame: Baseline, Week 24
measure: Number of Subjects With Response Rate According to Percent Decrease in Body Weight for Subgroups
timeFrame: Baseline, Week 24
measure: Percentage Change From Baseline on Waist Circumference
timeFrame: Baseline, Week 24 (Epoch 3), Week 24 to Week 48 (Epoch 4)
measure: Change From Baseline in Fasting Plasma Glucose (FPG) in Type 2 Diabetes Mellitus Patients (T2DM)
timeFrame: Baseline, Week 24 (Epoch 3), Week 24 to Week 48 (Epoch 4)
measure: Change From Baseline in Glycated Hemoglobin A1c (HbA1c) in Type 2 Diabetes Mellitus Patients (T2DM)
timeFrame: Baseline, Week 24 (Epoch 3), Week 24 to week 48 (Epoch 4)
measure: Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP)
timeFrame: Baseline, Week 24 (Epoch 3) Week 24 to Week 48 (Epoch 4)
measure: Change From Baseline in 24-hour Urinary Glucose Excretion
timeFrame: Baseline, week 24 (Epoch 3), Week 24 to Week 48 (Epoch 4)
measure: Percentage Change in Weight in the Overall Population and by Subgroups (Epoch 4)
timeFrame: Between Week 24 and Week 48 (Epoch 4)
measure: Change From Baseline to Week 24 (Epoch 3) in the 24-hour Urinary Calcium Excretion
timeFrame: Baseline, Week 24
measure: Change From Baseline Week 24 to Week 48 (Epoch 4) in the 24-hour Urinary Calcium Excretion
timeFrame: Baseline, Week 24, Week 48
measure: Change From Baseline to Week 24 (Epoch 3) in the 24-hour Urinary Phosphorus Excretion
timeFrame: Week 24, Week 48
measure: Change From Baseline Week 24 to Week 48 (Epoch 4) in the 24-hour Urinary Phosphorus Excretion
timeFrame: Week 24, Week 48
measure: Change From Baseline in Fasting Lipid Profile (Lipoproteins)
timeFrame: Baseline, Week 24, Week 24 to Week 48 (Epoch 4)
measure: Change From Baseline in High Sensitive C-reactive Protein (hsCRP)
timeFrame: Baseline to Week 24, Week 24 to Week 48 (Epoch 4)
measure: Change From Baseline in Fasting Lipid Profile (Triglycerides/Cholesterol)
timeFrame: Baseline to Week 24, Week 24 to Week 48 (Epoch 4)
measure: Pharmacokinetics of LIK066: Observe Maximum Plasma Concentration (Cmax)
timeFrame: Summary at Week 24 from qd or bid regimens
measure: Pharmacokinetics of LIK066: Time to Reach the Maximum Concentration (Tmax)
timeFrame: Summary at Week 24 for qd or bid regimens
measure: Pharmacokinetics of LIK066: Area Under the Plasma Concentration-time Curve From Time Zero Time 't' (AUC0-t)
timeFrame: Summary at Week 24 from qd or bid regimens (0-6h)
measure: Pharmacokinetics of LIK066: Last Non-zero Concentration Area Under the Curve (AUClast)
timeFrame: Summary at Week 24 from qd or bid regimens
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Novartis Investigative Site
state: Alabama
city: Jasper
country: United States
facility: Novartis Investigative Site
state: Alabama
city: Beverly Hills
country: United States
facility: Novartis Investigative Site
state: California
city: Carmichael
country: United States
facility: Novartis Investigative Site
state: California
city: Concord
country: United States
facility: Novartis Investigative Site
state: California
city: Los Angeles
country: United States
facility: Novartis Investigative Site
state: California
city: Northridge
country: United States
facility: Novartis Investigative Site
state: California
city: Roseville
country: United States
facility: Novartis Investigative Site
state: California
city: San Ramon
country: United States
facility: Novartis Investigative Site
state: California
city: Stockton
country: United States
facility: Novartis Investigative Site
state: California
city: Walnut Creek
country: United States
facility: Novartis Investigative Site
state: California
city: Denver
country: United States
facility: Novartis Investigative Site
state: Colorado
city: Golden
country: United States
facility: Novartis Investigative Site
state: Colorado
city: Bradenton
country: United States
facility: Novartis Investigative Site
state: Florida
city: Fort Lauderdale
country: United States
facility: Novartis Investigative Site
state: Florida
city: Port Charlotte
country: United States
facility: Novartis Investigative Site
state: Florida
city: West Palm Beach
country: United States
facility: Novartis Investigative Site
state: Florida
city: Athens
country: United States
facility: Novartis Investigative Site
state: Georgia
city: Augusta
country: United States
facility: Novartis Investigative Site
state: Georgia
city: Honolulu
country: United States
facility: Novartis Investigative Site
state: Hawaii
city: Gurnee
country: United States
facility: Novartis Investigative Site
state: Illinois
city: Springfield
country: United States
facility: Novartis Investigative Site
state: Illinois
city: Wauconda
country: United States
facility: Novartis Investigative Site
state: Illinois
city: Evansville
country: United States
facility: Novartis Investigative Site
state: Indiana
city: Evansville
country: United States
facility: Novartis Investigative Site
state: Indiana
city: Indianapolis
country: United States
facility: Novartis Investigative Site
state: Indiana
city: Louisville
country: United States
facility: Novartis Investigative Site
state: Kentucky
city: Baton Rouge
country: United States
facility: Novartis Investigative Site
state: Louisiana
city: Covington
country: United States
facility: Novartis Investigative Site
state: Louisiana
city: Hammond
country: United States
facility: Novartis Investigative Site
state: Louisiana
city: Metairie
country: United States
facility: Novartis Investigative Site
state: Louisiana
city: New Orleans
country: United States
facility: Novartis Investigative Site
state: Louisiana
city: New Orleans
country: United States
facility: Novartis Investigative Site
state: Louisiana
city: Baltimore
country: United States
facility: Novartis Investigative Site
state: Maryland
city: Beltsville
country: United States
facility: Novartis Investigative Site
state: Maryland
city: Towson
country: United States
facility: Novartis Investigative Site
state: Maryland
city: Royal Oak
country: United States
facility: Novartis Investigative Site
state: Michigan
city: Saint Louis
country: United States
facility: Novartis Investigative Site
state: Missouri
city: Saint Peters
country: United States
facility: Novartis Investigative Site
state: Missouri
city: Missoula
country: United States
facility: Novartis Investigative Site
state: Montana
city: Omaha
country: United States
facility: Novartis Investigative Site
state: Nebraska
city: Bronx
country: United States
facility: Novartis Investigative Site
state: New York
city: New York
country: United States
facility: Novartis Investigative Site
state: New York
city: New York
country: United States
facility: Novartis Investigative Site
state: New York
city: Hickory
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Lansdale
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Moncks Corner
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Mount Pleasant
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Summerville
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Houston
country: United States
facility: Novartis Investigative Site
state: Texas
city: Bountiful
country: United States
facility: Novartis Investigative Site
state: Utah
city: Salt Lake City
country: United States
facility: Novartis Investigative Site
state: Utah
city: Newport News
country: United States
facility: Novartis Investigative Site
state: Virginia
city: Richmond
country: United States
facility: Novartis Investigative Site
state: Virginia
city: Richmond
country: United States
facility: Novartis Investigative Site
state: Virginia
city: Renton
country: United States
facility: Novartis Investigative Site
state: Washington
city: Tacoma
country: United States
facility: Novartis Investigative Site
state: Washington
city: Kenosha
country: United States
facility: Novartis Investigative Site
state: Wisconsin
city: Graz
country: Austria
facility: Novartis Investigative Site
city: Wien
country: Austria
facility: Novartis Investigative Site
city: Wien
country: Austria
facility: Novartis Investigative Site
city: Toronto
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Toronto
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Gatineau
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Levis
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Praha 2
country: Czechia
facility: Novartis Investigative Site
state: Czech Republic
city: Ceske Budejovice
country: Czechia
facility: Novartis Investigative Site
city: Olomouc Lazce
country: Czechia
facility: Novartis Investigative Site
city: Praha 1
country: Czechia
facility: Novartis Investigative Site
city: Praha 3
country: Czechia
facility: Novartis Investigative Site
city: Slany
country: Czechia
facility: Novartis Investigative Site
city: Csongrad
country: Hungary
facility: Novartis Investigative Site
city: Nyiregyhaza
country: Hungary
facility: Novartis Investigative Site
city: Szentes
country: Hungary
facility: Novartis Investigative Site
city: Bratislava
country: Slovakia
facility: Novartis Investigative Site
city: Kosice
country: Slovakia
facility: Novartis Investigative Site
city: Sered
country: Slovakia
facility: Novartis Investigative Site
city: Basingstoke
country: United Kingdom
facility: Novartis Investigative Site
city: Blackburn
country: United Kingdom
facility: Novartis Investigative Site
city: Exeter
country: United Kingdom
facility: Novartis Investigative Site
city: Rotherham
country: United Kingdom
facility: Novartis Investigative Site
city: Stevenage
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: