Safety Study of LLF580 in Obese Volunteers
Status: | Recruiting |
---|---|
Conditions: | Obesity Weight Loss |
Therapuetic Areas: | Endocrinology |
Healthy: | No |
Age Range: | 18 - 65 |
Updated: | 12/5/2018 |
Start Date: | February 26, 2018 |
End Date: | June 24, 2019 |
Contact: | Novartis Pharmaceuticals |
Email: | novartis.email@novartis.com |
Phone: | 1-888-669-6682 |
A 12 Week Phase Ib Randomized Investigator and Subject Blinded Placebo Controlled Repeat-dose Study of LLF580
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.
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.
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.
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