A Phase 2 12-week multi-center, randomized, double-blind, placebo-controlled, parallel-group adaptive design study to evaluate the safety and efficacy of LCQ908 for weight reduction and reduced LDL cholesterol in patients with obesity and mixed dyslipidemia.
- Conditions
- Obesity and mixed dyslipidemiaMedDRA version: 9.1Level: LLTClassification code 10029883Term: ObesityMedDRA version: 9.1Level: LLTClassification code 10058110Term: Dyslipidemia
- Registration Number
- EUCTR2009-010198-19-GB
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 450
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 <30 pg/ml ; (b) 6 weeks post-surgical bilateral oophorectomy with or without hysterectomy; or (c) have a documented history of tubal ligation at least 1 year prior to screening.
4.Patients with a history of overweight for 1 year or more with body mass index (BMI) of 30 to 42 kg/m2 inclusive.
5.Body weight at Visit 1 within 5% of their self-reported weight over the past three months and agreement to maintain the study-recommended diet (counseled during screening) and usual exercise habits during the full course of the study. Patients will not have participated in a formal weight loss program within the 3 months prior to screening Visit 1.
6.Patients with fasting mixed dyslipidemia at the first screening visit including:
- elevated LDL cholesterol of 2.6 to 4.14 mmol/L (100-160 mg/dl) inclusive
and either
- fasting triglycerides of 1.7 to 5.0 mmol/L (150-520 mg/dl) inclusive
or
- HDL cholesterol in men <1.1 mmol/L (<42 mg/dl) and in women <1.3 mmol/L (<50 mg/dl)
7.Patients who are receiving a statin must meet the dyslipidemia criteria while on their statin and must have been on a stable dose for at least 2 months prior to the Visit 1 fasting lipids and safety screening. They must agree to maintain the same dose of statin throughout the trial duration.
8.Patients who have not been on fibrate or nicotinic (niacin) lipid lowering therapies within 2 months of Visit 1 are eligible for screening so long as they meet all other criteria. Patients on over-the-counter fish oils, prescription fish oils (Lovaza up to 4 g/day) or other natural product approaches to lipid lowering may remain on those as long as they meet other entry criteria.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method