A study to evaluate the change in weight after 24 weeks treatment with LIK066 in obese or overweight adults

• Register: EUCTR
• Last refreshed on: 1 October 2018
• Main ID: EUCTR2016-002868-14-SK
• Date of registration: 01/03/2017
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma AG
• Public title: A study to evaluate the change in weight after 24 weeks treatment with LIK066 in obese or overweight adults
• Scientific 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 - To evaluate the change in weight after 24 weeks treatment with LIK066 in obese or overweight adults
• Date of first enrolment: 18/04/2017
• Target sample size: 600
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-002868-14
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: no; Number of treatment arms in the trial: 9
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Austria, Canada, Czech Republic, Hungary, Slovakia, United Kingdom, United States

Contacts

• Name: DRA information desk
• Affiliation: Novartis Slovakia s.r.o.

• Name: DRA information desk
• Affiliation: Novartis Slovakia s.r.o.

Key inclusion & exclusion criteria

Inclusion criteria:
1. informed consent.
2. (BMI>=30) or (BMI>=27 with history of CV disease, hypertension, dyslipidemia, prediabetes
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).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 416
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 184

Exclusion criteria:
- Hypersensitivity to any of the study medications.
- Pregnancy or lactating women.
- History of malignancies.
- Use of pharmacologically acitive weight loss products.
- Bariatric surgery.
- History of ketoacidosis, lactic acidosis, or hyperosmolar coma.
- HbA1c >10% at the screening visit.
- Symptomatic genital infection or urinary tract infection (UTI) in the 4 weeks prior to screening, or between screening and randomization.
- Gastro-intestinal (GI) disorders associated with chronic diarrhea.
- Congestive heart failure, New York Heart Association (NYHA) class III or IV.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

change in weight in obese or overweight adults
MedDRA version: 20.0 Level: PT Classification code 10029883 Term: Obesity System Organ Class: 10027433 - Metabolism and nutrition disorders
MedDRA version: 20.0 Level: PT Classification code 10033307 Term: Overweight System Organ Class: 10027433 - Metabolism and nutrition disorders

Intervention(s)

Product Name: LIK066 2.5 mg
Product Code: LIK066
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: not available
Other descriptive name: LIK066
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.5-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Product Name: LIK066 10 mg
Product Code: LIK066
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: not available
Other descriptive name: LIK066
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Product Name: LIK066 25 mg
Product Code: LIK066
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: not available
Other descriptive name: LIK066
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Product Name: LIK066 50 mg
Product Code: LIK066
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: not available
Other descriptive name: LIK066
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Primary end point(s): Percent change from baseline in body weight at 24 weeks

Secondary Objective: - Responder rates according to percent decrease in body weight either = 5 % or = 10 % from baseline.
- Dose-response relationship for weight loss.
- Effect of all LIK066 doses and regimens vs placebo on change:
-in waist circumference
-from baseline in glycated hemoglobin A1c
-from baseline in fasting plasma glucose
-from baseline in blood pressure
-from baseline in fasting lipid profile and high sensitivity C-reactive protein
-from baseline in 24h urinary glucose excretion
- Change in weight in the overall population and by subgroups by LIK066 treatment vs placebo.
- 24h urinary calcium and phosphorus excretion in a subset of subjects.
- Area under the plasma concentration-time curve from time zero time 't' where t is a defined time point after administration.
- Observe maximum plasma concentration following administration of LIK066.
- Time to reach the maximum concentration after administration of LIK066.
- Last non-zero concentration area under the curve.

Main Objective: 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.

Timepoint(s) of evaluation of this end point: baseline, week 24

Secondary Outcome(s)

Secondary end point(s): - Number of subjects with response rate according to percent decrease in body weight.
- Number of subjects with response rate according to percent decrease in body weight by subgroup.
- Change from baseline on waist circumference.
- Change from baseline in glycated hemoglobin A1c.
- Change from baseline in fasting plasma glucose.
- Change from baseline in blood pressure.
- Change from baseline in fasting lipid profile and high sensitivity C-reactive protein.
- Change from baseline in 24-h urinary glucose excretion.
- Change in weight in the overall population and by subgroups by LIK066 treatment vs placebo at week 48.
- 24-h urinary calcium and phosphorus excretion.
- Pharmacokinetics of LIK066: Area under the plasma concentration-time curve from time zero time 't' (AUC0-t).
- Pharmacokinetics of LIK066: Observe maximum plasma concentration (cmax).
- Pharmacokinetics of LIK066: Time to reach the maximum concentration (Tmax).
- Pharmacokinetics of LIK066: Last non-zero concentration area under the curve (AUClast).

Timepoint(s) of evaluation of this end point: baseline, week 24, week 48

Secondary ID(s)

CLIK066B2201

Source(s) of Monetary Support

Novartis Pharma AG