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NCT05483998
A Study to Evaluate Single and Multiple Doses of TLC-2716 in Healthy Participants
Phase 1 trial testing TLC-2716 in Healthy Subjects in 100 participants. Completed in 18 June 2023.
13 April 2023
Quick facts
| Lead sponsor | OrsoBio, Inc |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | sequential |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 100 |
| Start date | 9 September 2022 |
| Primary completion | 13 April 2023 |
| Estimated completion | 18 June 2023 |
| Sites | 1 location across New Zealand |
Drugs / interventions tested
- TLC-2716
- Placebo
Conditions studied
- Healthy Subjects — all drugs for Healthy Subjects →
Sponsor
OrsoBio, Inc — full company profile →
Who can join
Adults 18 to 55, any sex, with Healthy Subjects. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Development of LXR inverse agonists to treat MAFLD, NASH, and other metabolic diseases.
Griffett K, Burris TP. · · 2023 · cited 26× · PMID 36817797 · DOI 10.3389/fmed.2023.1102469 -
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 -
Nuclear receptors as therapeutic targets in metabolic and cardiovascular disorders.
Li F, Chen Q, Dai Y, Lu L. · · 2025 · PMID 41438090 · DOI 10.1016/j.isci.2025.114042
Verify or expand the search:
- PubMed search for NCT05483998
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05483998 (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: 20 May 2024
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/NCT05483998.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing