Obesity
Conditions
Keywords
obesity, hypertriglyceridemia
Brief summary
The purpose of the study is to evaluate the safety and tolerability of multiple doses of LLF580 administered subcutaneously over 3 months in obese subjects. In addition, the study will also determine early efficacy signals in various metabolic diseases associated with elevated triglycerides and/or obesity.
Interventions
BIOLOGICALLLF580
LLF580 300mg
DRUGPlacebo
Placebo to LLF580
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Body mass index (BMI) within the range of 30 to 45 kg/m2, inclusive, with ethnic adjustment (≥27.5 kg/m2 for Asian individuals). * Fasting triglyceride 150 - 500 mg/dL (1.69 - 5.65 mmol/L), inclusive, at screening. * Able to communicate well with the investigator, to understand and comply with the requirements of the study.
Exclusion criteria
* History of hepatobilliary disease. * Liver disease or liver injury as indicated by abnormal liver function tests. * Chronic infection with Human Immunodeficiency Virus (HIV), Hepatitis B (HBV) or Hepatitis C (HCV). * Fasting triglycerides greater than or equal to 500 mg/dL \[5.65 mmol/L\], or concomitant use of drug treatment for hypertriglyceridemia (fibrates, omega-3 fatty acids, nicotinic acid). * History of pancreatic injury or pancreatitis. * History of hypersensitivity to drugs of similar biological class, FGF21 protein analogue, or Fc fusion proteins. * History of bone disorders or low vitamin D level. * Contraindications to MRI. * Change in body weight (more than 5% self-reported OR 5 kg self-reported change during the previous 3 months). * Use of weight loss drugs. * Enrollment in a diet, weight loss or exercise programs.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability following repeated dosing of LLF580 | 12 weeks | To assess the safety and tolerability in obese subjects following repeated dosing of LLF580 by subcutaneous (SC) injection over 12 weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| serum CTX-1, P1NP, and osteocalcin | 12 weeks | To assess the potential effects of LLF580 on these biomarkers. |
| Body weight | 12 weeks | To assess the effects of LLF580 on weight. |
| BMI | 12 weeks | To assess the effects of LLF580 on BMI |
| LDL-C, HDL-C | 12 weeks | To assess the effects of LLF580 on lipid profiles. |
| urine NTX-1 | 12 weeks | To assess the potential effects of LLF580 on these biomarkers. |
| Total cholesterol | 12 weeks | To asses the effects of LLF580 on lipid profiles |
| Triglycerides (fasting) | 12 weeks | To assess the effects of LLF580 on lipid profiles |
| serum BSAP | 12 weeks | To assess the potential effects of LLF580 on these biomarkers. |
Countries
United States
Outcome results
None listed