Safety Study of LLF580 in Obese Volunteers (NCT03466203) | Clinical Trial Compass
CompletedPhase 1
Safety Study of LLF580 in Obese Volunteers
United States61 participantsStarted 2018-02-26
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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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.
What they're measuring
1
Number of Participants with Adverse Events as a Measure of Safety and Tolerability following repeated dosing of LLF580