Drugs / TLC-2716
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial · 1 met primary | ||||||
| Phase 1 | NCT05483998 | Sep 2022 → Apr 2023 | — | OrsoBio, Inc | Completed | Met primary |
| Phase 21 trial | ||||||
| Phase 2 | NCT06564584 | Aug 2024 → Jun 2025 overdue | NAFLD1, hypertriglyceridemia | OrsoBio, Inc | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2026-06-14 | OrsoBio, Inc | Results OrsoBio Presents Positive Phase 2a Data for LXR Inverse Agonist TLC-2716 in Severe Hypertriglyceridemia and MASLD at ENDO 2026 orsobio.com ↗ |
| 2026-02-10 | OrsoBio, Inc | Results OrsoBio Announces Positive Topline Phase 2a Data for LXR Inverse Agonist TLC-2716 in Severe Hypertriglyceridemia and Metabolic Liver Disease orsobio.com ↗
The study met its primary efficacy endpoint, demonstrating reductions in fasting triglycerides at week four, and showed clinically meaningful improvements in remnant cholesterol and hepatic fat. |
| 2026-01-16 | OrsoBio, Inc | Results OrsoBio Announces Nature Medicine Publication Establishing Clinical and Mechanistic Validation of First-in-Class LXR Inverse Agonist TLC-2716 for the Treatment of Serious Metabolic Diseases orsobio.com ↗
The publication reports favorable safety and tolerability, along with robust lipid-lowering activity of TLC-2716 in healthy volunteers, with close concordance to human genetic evidence and results from human liver organoids, dysmetabolic rodent models, and non-human primates. |
| 2023-11-06 | OrsoBio, Inc | Results OrsoBio to Present Phase 1 Data for the Liver-Targeted LXR Inverse Agonist TLC-2716 in Development for Severe Hypertriglyceridemia and NASH at AHA’s Scientific Sessions 2023 orsobio.com ↗
OrsoBio, Inc., a clinical-stage biopharmaceutical company developing treatments for severe metabolic disorders, today announced initial safety, pharmacokinetic (PK), and pharmacodynamic data from its first-in-human, Phase 1 study of TLC-2716, a liver-targeted inverse agonist (inhibitor) of the Liver X Receptor (LXR). |
| 2022-11-03 | OrsoBio, Inc | Results OrsoBio Announces Presentation of Five Abstracts at AASLD’s The Liver Meeting® 2022 Highlighting Programs for Severe Metabolic Disorders orsobio.com ↗
In dysmetabolic rodents, TLC-2716 led to profound improvements in plasma and liver triglycerides, plasma cholesterol, and glucose tolerance. |
All press releases naming this drug 5 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | TLC-2716 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05483998 ↗ |
| Route | Oral | “TLC-2716, an orally administered, gut- and liver-restricted LXR inverse agonist.” PMID 41545590 ↗ Jan 2026 |