Safety Study of LLF580 in Obese Volunteers

• Status: Completed
• Trial end date: 2019-11-13
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

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.