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.

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.

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com