NCT03765294 is a Phase 1 clinical trial of ACT-541468 in Obstructive Sleep Apnea, sponsored by Idorsia Pharmaceuticals Ltd..

Who is sponsoring NCT03765294?

NCT03765294 is sponsored by Idorsia Pharmaceuticals Ltd..

What drugs are being tested in NCT03765294?

Interventions in NCT03765294: ACT-541468, Placebo.

What condition does NCT03765294 study?

NCT03765294 studies Obstructive Sleep Apnea.

Is NCT03765294 still recruiting?

NCT03765294 is currently completed. Last updated 19 December 2019.

Last reviewed 2019-12-19 · How we verify

NCT03765294

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

A Study to Investigate the Effects of ACT-541468 on Nighttime Respiratory Function in Patients With Mild to Moderate Obstructive Sleep Apnea

Completed Phase 1 Last updated 19 December 2019

What this trial tests

Phase 1 trial testing ACT-541468 in Obstructive Sleep Apnea in 28 participants. Completed in 5 November 2019.

Timeline

14 March 2019

Primary endpoint
5 November 2019

5 November 2019

Quick facts

Lead sponsor	Idorsia Pharmaceuticals Ltd.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	treatment
Enrollment	28
Start date	14 March 2019
Primary completion	5 November 2019
Estimated completion	5 November 2019
Sites	1 location across Germany

Drugs / interventions tested

ACT-541468 — full drug profile →
Placebo

Conditions studied

Obstructive Sleep Apnea — all drugs for Obstructive Sleep Apnea →

Sponsor

Idorsia Pharmaceuticals Ltd. — full company profile →

Who can join

18 and older, any sex, with Obstructive Sleep Apnea. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is conducted to investigate the effects of ACT-541468 on nighttime respiratory function in patients with mild to moderate obstructive sleep apnea

Publications & conference data

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

Daridorexant: First Approval.
Markham A. · · 2022 · cited 45× · PMID 35298826 · DOI 10.1007/s40265-022-01699-y
Effect of the new dual orexin receptor antagonist daridorexant on nighttime respiratory function and sleep in patients with mild and moderate obstructive sleep apnea.
Boof ML, Dingemanse J, Lederer K, Fietze I, et al · · 2021 · cited 28× · PMID 33305817 · DOI 10.1093/sleep/zsaa275
Advances in Molecular Pathology of Obstructive Sleep Apnea.
Zhang M, Lu Y, Sheng L, Han X, et al · · 2022 · cited 11× · PMID 36500515 · DOI 10.3390/molecules27238422
Daridorexant, a Recently Approved Dual Orexin Receptor Antagonists (DORA) in Treatment of Insomnia.
Sarathi Chakraborty D, Choudhury S, Lahiry S. · · 2023 · cited 8× · PMID 37425970 · DOI 10.1055/s-0043-1770805
Assessment of the effect of the dual orexin receptor antagonist daridorexant on various indices of disease severity in patients with mild to moderate obstructive sleep apnea.
Boof ML, Ufer M, Fietze I, Pépin JL, et al · · 2022 · cited 8× · PMID 35306405 · DOI 10.1016/j.sleep.2021.11.015
The Effects of Daridorexant on Patients With Comorbid Insomnia Disorder and Untreated Mild Obstructive Sleep Apnoea: A Post Hoc Subgroup Analysis of a Phase 3, Randomised Clinical Trial.
Lettieri CJ, Briasoulis O, Léger D, Luyet PP, et al · · 2026 · cited 2× · PMID 40660750 · DOI 10.1111/jsr.70135

Verify or expand the search:

Other trials of ACT-541468

Trials testing the same drug.

NCT04024332 — Study of the Way the Body Takes up, Distributes, and Gets Rid of ACT-541468 in Subjects With Abnormal Kidney Function Co · Phase 1 · completed
NCT03892902 — A Clinical Study to Assess Next-day Driving Performance Following Administration of ACT-541468 in Middle-aged and Elderl · Phase 1 · completed
NCT03799978 — A Clinical Study to Investigate the Food Effect on the Pharmacokinetics of ACT-541468 in Healthy Male Subjects · Phase 1 · completed
NCT03646864 — A Study to Evaluate the Effects of ACT-541468 on Respiration in Patients With Moderate Chronic Obstructive Pulmonary Dis · Phase 1 · completed
NCT03657355 — Study to Evaluate the Abuse Potential of ACT-541468 in Healthy Recreational Drug Users · Phase 1 · completed

Other recruiting trials for Obstructive Sleep Apnea

Currently open trials in the same condition.

NCT07195253 — Oro-myofunctional Characteristics and Obstructive Sleep Apnea in Infants With Down Syndrome · recruiting
NCT07273019 — Tongue Muscular Assessment in Children With Sleep Disordered Breathing · NA · recruiting
NCT07447011 — Glaucoma Respsosne to Lifestyle Corrections in Sleep Apnea · NA · recruiting
NCT07397780 — RPMO2 Oximeter Accuracy During Sleep 1 Trial · active not recruiting
NCT06698809 — Obstructive Sleep Apnea Therapeutic Intervention for REsiDual Sleepiness · NA · recruiting

Other Idorsia Pharmaceuticals Ltd. trials

Trials by the same sponsor.

NCT06799884 — A Drug-drug Interaction Trial in Healthy Female Participants to Investigate the Effect of Aprocitentan on Combined Hormo · Phase 1 · completed
NCT05877222 — A Phase 1 Trial to Investigate the Biological Equivalence of 5 × 10 mg Tablets and 2 × 25 mg Tablets of Daridorexant in · Phase 1 · completed
NCT05597020 — A Study to Find Out if Daridorexant is Safe and Efficacious in Patients With Insomnia and Comorbid Nocturia · Phase 4 · completed
NCT05632393 — A Study to Measure Daridorexant in Breast Milk of Healthy Lactating Women · Phase 1 · completed
NCT05702177 — A Study of the Effect of Daridorexant on Nighttime Body Posture, the Noise Level Required to Wake up, and the Ability to · 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 NCT03765294 (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 Idorsia Pharmaceuticals Ltd.
Last refreshed: 19 December 2019

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/NCT03765294.

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