Safety Study of LLF580 in Obese Volunteers

Obesity Clinical Trial

Official title:

A 12 Week Phase Ib Randomized Investigator and Subject Blinded Placebo Controlled Repeat-dose Study of LLF580

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03466203
• Other study ID #: CLLF580X2102
• Status: Completed
• Phase: Phase 1
• Start date: February 26, 2018
• Est. completion date: November 13, 2019

Study information

• Verified date: October 2021
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: November 13, 2019
• Est. primary completion date: November 13, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity

Intervention

Biological:
• LLF580
LLF580 300mg

Drug:
• Placebo
Placebo to LLF580

Locations

Country	Name	City	State
United States	Novartis Investigative Site	High Point	North Carolina
United States	Novartis Investigative Site	Jacksonville	Florida
United States	Novartis Investigative Site	Knoxville	Tennessee
United States	Novartis Investigative Site	Lincoln	Nebraska
United States	Novartis Investigative Site	Miami	Florida
United States	Novartis Investigative Site	Overland Park	Kansas
United States	Novartis Investigative Site	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability following repeated dosing of LLF580	To assess the safety and tolerability in obese subjects following repeated dosing of LLF580 by subcutaneous (SC) injection over 12 weeks.	12 weeks
Secondary	LDL-C, HDL-C	To assess the effects of LLF580 on lipid profiles.	12 weeks
Secondary	serum CTX-1, P1NP, and osteocalcin	To assess the potential effects of LLF580 on these biomarkers.	12 weeks
Secondary	Body weight	To assess the effects of LLF580 on weight.	12 weeks
Secondary	BMI	To assess the effects of LLF580 on BMI	12 weeks
Secondary	serum BSAP	To assess the potential effects of LLF580 on these biomarkers.	12 weeks
Secondary	urine NTX-1	To assess the potential effects of LLF580 on these biomarkers.	12 weeks
Secondary	Total cholesterol	To asses the effects of LLF580 on lipid profiles	12 weeks
Secondary	Triglycerides (fasting)	To assess the effects of LLF580 on lipid profiles	12 weeks

External Links

•   A Plain Language Trial Summary is available on novartisclinicaltrials.com
•   Results for CLLF580X2102 can be found on the Novartis Clinical Trial Results Website