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

Phase 1

• Conditions: change in weight in obese or overweight adults; MedDRA version: 20.0Level: PTClassification code 10029883Term: ObesitySystem Organ Class: 10027433 - Metabolism and nutrition disorders; MedDRA version: 20.0Level: PTClassification code 10033307Term: OverweightSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2016-002868-14-SK
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-01
• Last Update Posted: 1 October 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 600

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified