NCT07461220

Safety and Tolerability of IRL757 in Participants With Parkinson's Disease and Apathy

A Phase 1b, Prospective, Randomized, Double-blind, Placebo-controlled Trial Evaluating the Safety and Tolerability of Multiple Oral Doses of IRL757 in Participants With Parkinson's Disease and Apathy

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: Integrative Research Laboratories AB · Industry
• Sex: All
• Age: 50 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial's goal is to evaluate if the IRL757 is safe and has a good tolerability in participants with Parkinson's disease and experiencing apathy (a lack of interest or motivation). In addition, the trial is aiming to learn if IRL757 has effects on the symptoms of Parkinson's disease. Researchers will compare the effects of IRL757 to a placebo (a look-alike substance that contains no drug). Participants who fit the study criteria will be treated with the study drug (either the active drug IRL757 or placebo) for 12 weeks and will visit the clinic at 5 defined timepoints for check-ups and tests. A follow-up call after the end of treatment will be done 4 weeks after the last study drug intake.

Conditions

• PARKINSON DISEASE (Disorder)
• Apathy
• Safety

Interventions

Type	Name	Description
DRUG	IRL757	IRL757 will be administered daily for 12 weeks. The study drug is available as capsules for oral administration.
DRUG	Placebo	The study drug is administered daily for 12 weeks. The placebo is available in form of capsules to be administered orally.

Timeline

• Start date: 2026-02-18
• Primary completion: 2027-05-01
• Completion: 2027-05-01
• First posted: 2026-03-10
• Last updated: 2026-03-10

Locations

13 sites across 4 countries: Bulgaria, Germany, Poland, Spain