Obesity and mixed dyslipidemia MedDRA version: 9.1 Level: LLT Classification code 10029883 Term: Obesity MedDRA version: 9.1 Level: LLT Classification code 10058110 Term: Dyslipidemia
Conditions
Interventions
Product Code: LCQ908
Pharmaceutical Form: Tablet
Current Sponsor code: LCQ908
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2-
Pharmaceutical form of the placebo:
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Written informed consent to participate in the study, before any study related activities are performed, and is likely to comply with all study requirements, including dietary guidelines. 2.Age 18-75 years, inclusive. 3.Males, non-fertile females, and females of non-childbearing potential. Women must be (a) postmenopausal, defined as age >48 with 12 months of natural (i.e. spontaneous) amenorrhea or age >42 with >6 months of spontaneous amenorrhea with serum FSH levels > 30 mIU/mL and estradiol =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.A history of type 1 diabetes or diagnosed type 2 diabetes, or other forms of diabetes mellitus. Women with a history of gestational diabetes occurring 5 or more years prior to screening are eligible if they meet the other metabolic criteria 2.Fasting plasma glucose > 7.0 mmol/L (>126 mg/dl) or HgbA1c >6.5 % 3.Known endocrine disorders that result in obesity including hypothalamic disorders, Cushing’s disease or recently diagnosed (within the prior 6 months) hypothyroidism 4.Genetic obesity syndromes, including Prader-Willi Syndrome 5.Dyslipidemia syndromes that require nicotinic acid or fibrates for control or need for accelerated treatment, including Triglycerides >5.0 mmol/L (520 mg/dl) and LDL cholesterol > 4.14 nmol (160 mg/dl) 6.Patients with known Type I or Type V chylomicronemia 7.For patients considered for the MRI sub-study: claustrophobia, waist circumference exceeding the bore size of the MRI scanner, and presence of ferromagnetic implants such as older pacemakers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The co-primary objectives of the study are 1) to evaluate the potential efficacy and dose response of LCQ908 as a therapy for the treatment of obesity (weight loss) and 2) To evaluate the potential efficacy and dose response of LCQ908 as a treatment for the dyslipidemia (LDL-cholesterol) associated with the metabolic syndrome. The trial will be declared positive if either one or both primary endpoints are met.;Secondary Objective: Secondary objectives are to evaluate the effects of LCQ908 on weight loss status (= 5%, or < 5%), changes in waist circumference, insulin sensitivity, and specific elements of the lipid profile including chylomicron remnants and HDL subtypes. Additional objectives are to evaluate the effect on other features of the metabolic syndrome including blood pressure and markers of inflammation. Finally, an MRI substudy of the effect of LCQ908 on hepatic fat fraction (HFF) will provide pilot data regarding other potential therapeutic benefits in patients with non-alcoholic fatty liver disease (NALFD) or non-alcoholic steatohepatitis (NASH).;Primary end point(s): The primary efficacy variable is the change from baseline of HbA1c at 12 weeks (or the last available post-randomization value). | — |
Countries
Denmark, Spain, Sweden, United Kingdom
Outcome results
None listed