Status:
COMPLETED
A Dose-finding Study to Evaluate the Change in Weight After Treatment With LIK066 in Japanese Patients With Obesity
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Obesity
Eligibility:
All Genders
20-75 years
Phase:
PHASE2
Brief Summary
The purpose of the study is to evaluate the efficacy, tolerability and safety of LIK066 to support dose selection for Phase 3 development in Japanese adults with obesity disease.
Eligibility Criteria
Inclusion
- Patients with obesity disease and inadequately controlled body weight with diet and/or exercise
- BMI ≥ 25 kg/m\^2 combined with at least two obesity-related comorbidities, or BMI ≥ 35 kg/m\^2 at least one obesity-related comorbidity
- Patients with FPG ≥ 110 mg/dL and/or 5.6% ≤ HbA1c ≤ 10.0%, or T2DM with HbA1c ≤ 10.0%
- Waist circumference at umbilical level ≥ 85 cm for male, ≥ 90 cm for female
- Visceral fat area ≥ 100 cm\^2
- Agreement to comply with the study-required life-style intervention and treatment during the full duration of the study
Exclusion
- Pregnancy or lactating women
- Use of pharmacologically active weight-loss medications
- Bariatric surgery
- Ketoacidosis, lactic acidosis, hyperosmolar coma
- Symptomatic genital ingection or urinary tract infection in the 4 weeks prior to screening
- Gastro-intestinal (GI) disorders associated with chronic diarrhea
- Congestive heart failure, New York Heart Association (NYHA) class III or IV
Key Trial Info
Start Date :
December 7 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 25 2018
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT03320941
Start Date
December 7 2017
End Date
July 25 2018
Last Update
June 26 2024
Active Locations (24)
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1
Novartis Investigative Site
Matsudo, Chiba, Japan, 271 0077
2
Novartis Investigative Site
Chikushino-shi, Fukuoka, Japan, 818-0036
3
Novartis Investigative Site
Fukuoka, Fukuoka, Japan, 810-0066
4
Novartis Investigative Site
Fukuoka, Fukuoka, Japan, 819-0006