To evaluate the change in weight after 24 weeks treatment with LIK066
Research type
Research Study
Full title
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
IRAS ID
218603
Contact name
William David Strain
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2016-002868-14
Duration of Study in the UK
2 years, 4 months, days
Research summary
Obesity represents a rapidly growing threat to the health of populations worldwide. Obesity raises the risk of morbidity from hypertension, dyslipidemia, type 2 diabetes mellitus (T2DM), coronary heart disease, stroke, gallbladder disease, osteoarthritis, sleep apnea and respiratory problems, and some cancers. Obesity is also associated with increased risk in all-cause and cardiovascular (CV) disease mortality. The biomedical, psychosocial, and economic consequences of obesity have substantial health implications (AACE 2016). Diet and behaviour modification have been shown to be useful in producing effective, but modest weight loss leading to amelioration of comorbid medical problems. Clinical challenges remain with the magnitude of weight reduction (up to ~5 % vs placebo) and the maintenance of the achieved weight loss. Some of the available treatments have limitations for long term use due to their gastro-intestinal (GI) adverse effects, others due to central nervous system adverse effects. Therefore, there is a substantial opportunity and real need to develop weight loss medicines which will be more effective and better tolerated. LIK066 is an inhibitor of the sodium-glucose co-transporter-1 (SGLT1) and sodium-glucose co-transporter-2 (SGLT2). The dual mechanism (renal and intestinal) to reduce re-absorption/absorption of glucose leads to loss of calories (calorie-loss enhancer). It also has the potential to reduce food intake via central mechanisms mediated by an increase in incretin hormones (glucagon-like peptide-1 (GLP-1) and peptide YY). In a Phase I study with normo and dysglycemic adults with body mass index (BMI) ≥ 35 kg/m2, LIK066 150 mg once daily (qd) resulted in mean 5.7 % placebo subtracted weight loss at 12 weeks. It is important to find the optimal efficacy-tolerability dose of LIK066 for further clinical development. The current study is designed to evaluate the efficacy, tolerability and safety of a dose-range of LIK066 in overweight and obese adults.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
17/EM/0117
Date of REC Opinion
24 Apr 2017
REC opinion
Further Information Favourable Opinion