EUCTR2016-002868-14-HU
Active, not recruiting
Phase 1
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
Conditionschange in weight in obese or overweight adultsMedDRA version: 20.0Level: PTClassification code 10029883Term: ObesitySystem Organ Class: 10027433 - Metabolism and nutrition disordersMedDRA version: 20.0Level: PTClassification code 10033307Term: OverweightSystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- change in weight in obese or overweight adults
- Sponsor
- ovartis Pharma AG
- Enrollment
- 600
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
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.
Outcomes
Primary Outcomes
Not specified
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Phase 2
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