Safety Study of LLF580 in Obese Volunteers

• Sponsor: Novartis Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03466203
• Collaborator: (none)
• Enrollment: 61
• Locations: 7
• Arms: 2
• Actual Duration (Months): 20.5
• Patients Per Site: 8.7
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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 early efficacy signals in various metabolic diseases associated with elevated triglycerides and/or obesity.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Biological: LLF580; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 61 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: A 12 Week Phase Ib Randomized Investigator and Subject Blinded Placebo Controlled Repeat-dose Study of LLF580
• Actual Study Start Date: Feb 26, 2018
• Actual Primary Completion Date: Nov 13, 2019
• Actual Study Completion Date: Nov 13, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LLF580 LLF580 every 28 days * 3	Biological: LLF580; LLF580 300mg
Placebo Comparator: Placebo Placebo to LLF580 every 28 days * 3	Drug: Placebo; Placebo to LLF580

Outcome Measures

Primary Outcome Measures

1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability following repeated dosing of LLF580 [12 weeks]

   To assess the safety and tolerability in obese subjects following repeated dosing of LLF580 by subcutaneous (SC) injection over 12 weeks.

Secondary Outcome Measures

1. LDL-C, HDL-C [12 weeks]

   To assess the effects of LLF580 on lipid profiles.

2. serum CTX-1, P1NP, and osteocalcin [12 weeks]

   To assess the potential effects of LLF580 on these biomarkers.

3. Body weight [12 weeks]

   To assess the effects of LLF580 on weight.

4. BMI [12 weeks]

   To assess the effects of LLF580 on BMI

5. serum BSAP [12 weeks]

   To assess the potential effects of LLF580 on these biomarkers.

6. urine NTX-1 [12 weeks]

   To assess the potential effects of LLF580 on these biomarkers.

7. Total cholesterol [12 weeks]

   To asses the effects of LLF580 on lipid profiles

8. Triglycerides (fasting) [12 weeks]

   To assess the effects of LLF580 on lipid profiles

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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
5	Novartis Investigative Site	High Point	North Carolina	United States	27265
6	Novartis Investigative Site	Philadelphia	Pennsylvania	United States	19104
7	Novartis Investigative Site	Knoxville	Tennessee	United States	37920

Sponsors and Collaborators

• Novartis Pharmaceuticals

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Novartis Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT03466203
• Other Study ID Numbers: CLLF580X2102
• First Posted: Mar 15, 2018
• Last Update Posted: Oct 12, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Novartis Pharmaceuticals: obesity; hypertriglyceridemia
• Additional relevant MeSH terms: Obesity

Study Results

No Results Posted as of Oct 12, 2021