NCT06564584 is a Phase 2 clinical trial of TLC-2716 Dose 1 in Hypertriglyceridemia, sponsored by OrsoBio, Inc.

Who is sponsoring NCT06564584?

NCT06564584 is sponsored by OrsoBio, Inc.

What drugs are being tested in NCT06564584?

Interventions in NCT06564584: TLC-2716 Dose 1, TLC-2716 Dose 2, Placebo.

What condition does NCT06564584 study?

NCT06564584 studies Hypertriglyceridemia, Nonalcoholic Fatty Liver Disease.

Is NCT06564584 still recruiting?

NCT06564584 is currently recruiting now. Last updated 31 March 2025.

Last reviewed 2025-03-31 · How we verify

NCT06564584

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Phase 2a Study Evaluating the Safety, Tolerability, and Efficacy of TLC-2716 in Subjects With Hypertriglyceridemia and Nonalcoholic Fatty Liver Disease

Recruiting now Phase 2 Last updated 31 March 2025

What this trial tests

Phase 2 trial testing TLC-2716 Dose 1 in Hypertriglyceridemia in 30 participants. Currently enrolling.

Timeline

12 August 2024

Primary endpoint
1 June 2025

1 September 2025

Quick facts

Lead sponsor	OrsoBio, Inc
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	30
Start date	12 August 2024
Primary completion	1 June 2025
Estimated completion	1 September 2025
Sites	4 locations across Mexico

Drugs / interventions tested

TLC-2716 Dose 1 — full drug profile →
TLC-2716 Dose 2
Placebo

Conditions studied

Hypertriglyceridemia — all drugs for Hypertriglyceridemia →
Nonalcoholic Fatty Liver Disease — all drugs for Nonalcoholic Fatty Liver Disease →

Sponsor

OrsoBio, Inc — full company profile →

Who can join

Adults 18 to 70, any sex, with Hypertriglyceridemia or Nonalcoholic Fatty Liver Disease. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Change in fasting triglycerides
Time frame: Through study completion, up to Day 28 of the study
Relative (%) change in fasting triglycerides at Week 4 from baseline
Incidence of TLC-2716 treatment-emergent adverse events
Time frame: Through study completion, up to Day 28 of the study
Adverse events (AEs) - severity of the AEs will be graded using the Common Terminology Criteria for AE (CTCAE) (v5.0). The relationship between AEs and the study drug will be indicated as related or not related.

Sponsor's own description

This is a Phase 2a, randomized, double-blind, placebo-controlled study evaluating the safety, tolerability, and efficacy of 2 dose levels of TLC-2716 in subjects with hypertriglyceridemia and nonalcoholic fatty liver disease as assessed by changes in fasting triglycerides, liver steatosis by MRI, and other biomarkers.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

An oral, liver-restricted LXR inverse agonist for dyslipidemia: preclinical development and phase 1 trial.
Li X, Benegiamo G, Vijayakumar A, Sroda N, et al · · 2026 · cited 1× · PMID 41545590 · DOI 10.1038/s41591-025-04169-6

Verify or expand the search:

Other recruiting trials for Hypertriglyceridemia

Currently open trials in the same condition.

NCT07406191 — WB-EMS Effects on Cardiometabolic Risk Factors · NA · recruiting
NCT07004777 — Effect of Consuming n-3 Polyunsaturated Fatty Acids Rich Foods on Triglyceride Concentration and Lipoprotein Composition · NA · recruiting
NCT07140809 — a Phase 1b/2a Study of JMT202 Injection in Participants With Hypertriglyceridemia · Phase 1, PHASE2 · recruiting
NCT06494488 — Differential Thrombogenesis by EPA and DHA Mediated by HDL · EARLY_PHASE1 · recruiting
NCT06783881 — Single-ascending Dose Study of Kylo-12 in Healthy Subjects · Phase 1 · active not recruiting

Other OrsoBio, Inc trials

Trials by the same sponsor.

NCT07300189 — A Study to Evaluate Single and Multiple Doses of TLC-1180 in Healthy Subjects · Phase 1 · recruiting
NCT05483998 — A Study to Evaluate Single and Multiple Doses of TLC-2716 in Healthy Participants · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06564584 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by OrsoBio, Inc
Last refreshed: 31 March 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06564584.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing