Try our beta test site

Effect of LIK066 on Body Weight in Patients With Elevated Body Mass Index

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT02470403
First received: June 10, 2015
Last updated: April 25, 2016
Last verified: April 2016
  Purpose
A 12-week study to assess LIK066 effect on body weight in diabetics, prediabetics and normoglycemic patients with elevated body mass index (BMI)

Condition Intervention Phase
Elevated Body Mass Index
Drug: LIK066
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: A Randomized, Double-blind, Placebo-controlled, Parallel Group, 2-part Study Investigating the Effect of LIK066 on Body Weight in Dysglycemic (Prediabetes or Type 2 Diabetes) and Normoglycemic Patients With Elevated Body Mass Index

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Part 1: Percent change in body weight from baseline [ Time Frame: Baseline, Week 12 ]
    To assess the effect of a 12-week treatment with LIK066 on body weight in dysglycemic and normoglycemic patients with elevated BMI

  • Part 1: Number of patients with any adverse events, serious adverse events and death [ Time Frame: 12 weeks ]
    To assess the safety and tolerability of a 12-week treatment with LIK066 in dysglycemic and normoglycemic patients with elevated BMI

  • Part 2: Percent change in body weight from baseline [ Time Frame: Baseline, Week 2 ]
    To assess the effect of a 2-week treatment with LIK066 on body weight in dysglycemic and normoglycemic patients with elevated BMI

  • Part 2: Number of patients with any adverse events, serious adverse events and death [ Time Frame: 2 weeks ]
    To assess the safety and tolerability of a 2-week treatment with LIK066 in dysglycemic and normoglycemic patients with elevated BMI


Secondary Outcome Measures:
  • Mean change from baseline in body weight in dysglycemic patients and normoglycemic patients with elevated BMI [ Time Frame: Baseline, Week 2 ]
  • Maximum plasma concentration of LIK066 at steady state (Cmax ss) in Part 1 of the study [ Time Frame: Day 14, Day 56 and Day 70 Predose. Day 84: predose, 0.5, 1, 1.5, 2, 3, 4, 6 and 24 h postdose ]
  • Time to maximum plasma concentration of LIK066 at steady state (Tmax, ss) in Part 1 of the study [ Time Frame: Day 14, Day 56 and Day 70 Predose. Day 84: predose, 0.5, 1, 1.5, 2, 3, 4, 6 and 24 h postdose ]
  • Area under the plasma concentration-time profile to the time of the last quantifiable concentration at steady state (AUClast, ss) of LIK066 in Part 1 of the study [ Time Frame: Day 14, Day 56 and Day 70 Predose. Day 84: predose, 0.5, 1, 1.5, 2, 3, 4, 6 and 24 h postdose ]
  • Area under the plasma concentration-time profile to the time of next dosing at steady state (AUCtau, ss) of LIK066 in Part 1 of the study [ Time Frame: Day 14, Day 56 and Day 70 Predose. Day 84: predose, 0.5, 1, 1.5, 2, 3, 4, 6 and 24 h postdose ]
  • The apparent systemic clearance at steady state (CLss/F) of LIK066 following extra vascular administration in Part 1 of the study [ Time Frame: Day 14, Day 56 and Day 70 Predose. Day 84: predose, 0.5, 1, 1.5, 2, 3, 4, 6 and 24 h postdose ]
  • The apparent volume of distribution of LIK066 during the terminal elimination phase following extra vascular administration (Vz/F) in Part 1 of the study [ Time Frame: Day 14, Day 56 and Day 70 Predose. Day 84: predose, 0.5, 1, 1.5, 2, 3, 4, 6 and 24 h postdose ]
  • Maximum plasma concentration of LIK066 (Cmax) in Part 2 of the study [ Time Frame: Day 1: predose, 0.5, 1, 2, 3, 4, 4.5, 5, 6, 7 and 9 h postdose. Day 7 Predose. Day 14: predose, 0.5, 1, 2, 3, 4, 4.5, 5, 6, 7 and 9 h postdose ]
  • Maximum plasma concentration of LIK066 at steady state (Cmax ss) in Part 2 of the study [ Time Frame: Day 1: predose, 0.5, 1, 2, 3, 4, 4.5, 5, 6, 7 and 9 h postdose. Day 7 Predose. Day 14: predose, 0.5, 1, 2, 3, 4, 4.5, 5, 6, 7 and 9 h postdose ]
  • Time to maximum plasma concentration of LIK066 (Tmax) in Part 2 of the study [ Time Frame: Day 1: predose, 0.5, 1, 2, 3, 4, 4.5, 5, 6, 7 and 9 h postdose. Day 7 Predose. Day 14: predose, 0.5, 1, 2, 3, 4, 4.5, 5, 6, 7 and 9 h postdose ]
  • Time to maximum plasma concentration of LIK066 at steady state (Tmax, ss) in Part 2 of the study [ Time Frame: Day 1: predose, 0.5, 1, 2, 3, 4, 4.5, 5, 6, 7 and 9 h postdose. Day 7 Predose. Day 14: predose, 0.5, 1, 2, 3, 4, 4.5, 5, 6, 7 and 9 h postdose ]
  • Area under the plasma concentration-time profile to the time of the last quantifiable concentration (AUClast) of LIK066 in Part 2 of the study [ Time Frame: Day 1: predose, 0.5, 1, 2, 3, 4, 4.5, 5, 6, 7 and 9 h postdose. Day 7 Predose. Day 14: predose, 0.5, 1, 2, 3, 4, 4.5, 5, 6, 7 and 9 h postdose ]
  • Area under the plasma concentration-time profile to the time of the last quantifiable concentration at steady state (AUClast, ss) of LIK066 in Part 2 of the study [ Time Frame: Day 1: predose, 0.5, 1, 2, 3, 4, 4.5, 5, 6, 7 and 9 h postdose. Day 7 Predose. Day 14: predose, 0.5, 1, 2, 3, 4, 4.5, 5, 6, 7 and 9 h postdose ]
  • Area under the plasma concentration-time profile to the time of next dosing (AUCtau) of LIK066 in Part 2 of the study [ Time Frame: Day 1: predose, 0.5, 1, 2, 3, 4, 4.5, 5, 6, 7 and 9 h postdose. Day 7 Predose. Day 14: predose, 0.5, 1, 2, 3, 4, 4.5, 5, 6, 7 and 9 h postdose ]
  • Area under the plasma concentration-time profile to the time of next dosing at steady state (AUCtau, ss) of LIK066 in Part 2 of the study [ Time Frame: Day 1: predose, 0.5, 1, 2, 3, 4, 4.5, 5, 6, 7 and 9 h postdose. Day 7 Predose. Day 14: predose, 0.5, 1, 2, 3, 4, 4.5, 5, 6, 7 and 9 h postdose ]
  • The apparent systemic clearance at steady state (CLss/F) of LIK066 following extra vascular administration in Part 2 of the study [ Time Frame: Day 1: predose, 0.5, 1, 2, 3, 4, 4.5, 5, 6, 7 and 9 h postdose. Day 7 Predose. Day 14: predose, 0.5, 1, 2, 3, 4, 4.5, 5, 6, 7 and 9 h postdose ]
  • The apparent volume of distribution of LIK066 during the terminal elimination phase following extra vascular administration (Vz/F) in Part 2 of the study [ Time Frame: Day 1: predose, 0.5, 1, 2, 3, 4, 4.5, 5, 6, 7 and 9 h postdose. Day 7 Predose. Day 14: predose, 0.5, 1, 2, 3, 4, 4.5, 5, 6, 7 and 9 h postdose ]

Enrollment: 181
Study Start Date: June 2015
Study Completion Date: April 2016
Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LIK066 once daily
LIK066 once daily
Drug: LIK066
LIK066 25 mg tablets
Experimental: LIK066 three times daily
LIK066 three times daily
Drug: LIK066
LIK066 25 mg tablets
Placebo Comparator: Placebo once daily
Placebo once daily
Drug: Placebo
Matching placebo tablets
Placebo Comparator: Placebo three times daily
Placebo three times daily
Drug: Placebo
Matching placebo tablets
Experimental: LIK066 two times daily
LIK066 two times daily
Drug: LIK066
LIK066 25 mg tablets
Placebo Comparator: Placebo two times daily
Placebo two times daily
Drug: Placebo
Matching placebo tablets

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with stable health condition as determined by past medical history, physical examination, electrocardiogram, and laboratory tests at screening.
  • Patients with dysglycemia are patients with: Fasting plasma glucose >100mg/dL (5.6 mmol/L), or HbA1c > 5.7% and < 10% at screening.
  • Fasting plasma glucose ≤250mg/dL (13.9 mmol/L) at screening.
  • If treated with antidiabetic medications (other than prohibited medications), patients must be on a stable dose for 12 weeks prior to randomization and maintain the dose until the end of the study.
  • Subjects must have a body mass index (BMI) within the range of 35 - 50 kg/m2 at screening, with stable body weight (± 5 kg) within 3 months prior to screening

Exclusion Criteria:

  • Pre-existing, clinically significant gastrointestinal, liver, cardiovascular, renal or other chronic medical condition which is considered serious or unstable, other than stable cardiovascular disease, treated hypertension, dyslipidemia or other stable chronic disorders
  • Clinically significant GI disorder related to malabsorption or that may affect drug or glucose absorption or history of significant gastrointestinal surgery that could affect intestinal glucose absorption
  • Enrollment in a diet, weight loss or exercise programs with the specific intent of losing weight, within 3 months prior to randomization, or clinical diagnosis of any eating disorder
  • Pregnant or nursing (lactating) women, and women of child-bearing potential

Other inclusion/exclusion criteria may apply

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02470403

Locations
United States, Nebraska
Novartis Investigative Site
Lincoln, Nebraska, United States, 68502
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Study Director Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02470403     History of Changes
Other Study ID Numbers: CLIK066X2201
Study First Received: June 10, 2015
Last Updated: April 25, 2016

Keywords provided by Novartis:
dysglycemic, normoglycemic, prediabetes, type 2 diabetes mellitus

Additional relevant MeSH terms:
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on March 24, 2017