Status:
COMPLETED
Safety Study of LLF580 in Obese Volunteers
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Obesity
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 26 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 13 2019
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT03466203
Start Date
February 26 2018
End Date
November 13 2019
Last Update
October 12 2021
Active Locations (7)
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1
Novartis Investigative Site
Jacksonville, Florida, United States, 32216
2
Novartis Investigative Site
Miami, Florida, United States, 33126
3
Novartis Investigative Site
Overland Park, Kansas, United States, 66212
4
Novartis Investigative Site
Lincoln, Nebraska, United States, 68502