A Study to Evaluate Single and Multiple Doses of TLC-2716 in Healthy Participants

Phase 1 Completed 100 enrolled OrsoBio, Inc

RandomizedSequentialDouble-blindTreatment

Summary

This phase 1 study is designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of TLC-2716 after single- and multiple-ascending doses in healthy subjects.

Timeline

Start: 2022-09-09
Primary completion: 2023-04-13
Completion: 2023-06-18

Outcome

Met primary endpoint

paper 14-day treatment with TLC-2716 was well tolerated (primary endpoints) PMID 41545590 ↗

Publications

Li X, Benegiamo G, Vijayakumar A, Sroda N, Kimura M, Huss RS, Weng S, Murakami E, Kirby BJ, von Alvensleben GVG, Kremoser C, Gane EJ, Takebe T, Myers RP, Subramanian GM, Auwerx J. An oral, liver-restricted LXR inverse agonist for dyslipidemia: preclinical development and phase 1 trial. Nat Med. 2026 Mar;32(3):883-893. doi: 10.1038/s41591-025-04169-6. Epub 2026 Jan 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	TLC-2716	Unknown	—	Oral

Indications

No indication recorded.