NCT03466203

Safety Study of LLF580 in Obese Volunteers

Completed Phase 1 Last updated 12 October 2021

What this trial tests

Phase 1 trial testing LLF580 in Obesity in 61 participants. Completed in 13 November 2019.

Timeline

26 February 2018

Primary endpoint
13 November 2019

13 November 2019

Quick facts

Lead sponsor	Novartis Pharmaceuticals
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	61
Start date	26 February 2018
Primary completion	13 November 2019
Estimated completion	13 November 2019
Sites	7 locations across United States

Drugs / interventions tested

• LLF580 — full drug profile →
• Placebo

Conditions studied

• Obesity — all drugs for Obesity →

Sponsor

Novartis Pharmaceuticals — full company profile →

Who can join

Adults 18 to 65, any sex, with Obesity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Signaling pathways in obesity: mechanisms and therapeutic interventions.
   Wen X, Zhang B, Wu B, Xiao H, et al · · 2022 · cited 245× · PMID 36031641 · DOI 10.1038/s41392-022-01149-x
2. Targeting FGF21 in cardiovascular and metabolic diseases: from mechanism to medicine.
   Tan H, Yue T, Chen Z, Wu W, et al · · 2023 · cited 73× · PMID 36594101 · DOI 10.7150/ijbs.73936
3. Multivariate genome-wide analysis of aging-related traits identifies novel loci and new drug targets for healthy aging.
   Rosoff DB, Mavromatis LA, Bell AS, Wagner J, et al · · 2023 · cited 58× · PMID 37550455 · DOI 10.1038/s43587-023-00455-5
4. LLF580, an FGF21 Analog, Reduces Triglycerides and Hepatic Fat in Obese Adults With Modest Hypertriglyceridemia.
   Rader DJ, Maratos-Flier E, Nguyen A, Hom D, et al · · 2022 · cited 51× · PMID 34431493 · DOI 10.1210/clinem/dgab624
5. Targeting fibroblast growth factor (FGF)-21: a promising strategy for metabolic dysfunction-associated steatotic liver disease treatment.
   Cui X, Sun Q, Wang H. · · 2025 · cited 7× · PMID 40331190 · DOI 10.3389/fphar.2025.1510322
6. The role of nonmyocardial cells in the development of diabetic cardiomyopathy and the protective effects of FGF21: a current understanding.
   Zhang T, Jiang D, Zhang X, Chen L, et al · · 2024 · cited 4× · PMID 39327594 · DOI 10.1186/s12964-024-01842-0
7. Exploring endocrine FGFs - structures, functions and biomedical applications.
   Phan P, Ternier G, Edirisinghe O, Kumar TKS. · · 2024 · cited 4× · PMID 39309613 · DOI 10.62347/palk2137
8. Focus on Glucagon-like Peptide-1 Target: Drugs Approved or Designed to Treat Obesity.
   Zhang J, Wei J, Lai W, Sun J, et al · · 2025 · cited 2× · PMID 40004115 · DOI 10.3390/ijms26041651