The Woolcock Institute of Medical Research

Tuesday 20 May 2025 is International Clinical Trials Day, a time to reflect on some of the recent successes of the Woolcock Institute of Medical Research’s Sleep Clinical Trials team. Alongside the investigator-driven research we often report here, the Woolcock team has played a major role in recent industry-sponsored global clinical trials making huge impacts for patients worldwide. Under the leadership of Professor Ron Grunstein, the Sleep Trials Team has participated in trials for exciting new treatments for patients with disorders of hypersomnolence (narcolepsy and idiopathic hypersomnia) and obstructive sleep apnea.

Orexin receptor agonists are potential game-changers for the treatment of narcolepsy and idiopathic hypersomnia – with Phase 2 and 3 trials completed, underway, or about to start at the Woolcock. These new medications have been developed to mimic orexin, a neuropeptide that is linked with sleep and wake. Orexin is absent in patients with narcolepsy type 1 and this new class of medication is the first of its kind to target the cause of this disorder, instead of stimulant-type medication which only masks symptoms. These drugs have the potential to be life-changing for patients.

A DEDICATED TEAM

The Sleep Clinical Trials team has worked tirelessly since 2023 on the orexin agonist clinical trials programme, delivering remarkable results. The team were the major site globally for a Phase 1b clinical trial, recruiting 24 people in record time into a complex protocol. The study patients dedicated 11 consecutive days out of their busy lives to participate and the trials team with the help of the Woolcock’s amazing sleep technologists were on site 24 hours a day, 7 days a week during this time. Clinical trial managers Alison Wheaton and Tony Zakharia, supported by Sleep Research Manager Emma Funnell kept the team on track to deliver such a successful result. The team continues to work on global trials for orexin agonists as they move from Phase 1 clinical trials through Phase 2, 3 and hopefully towards eventual marketing approval for patients with narcolepsy and idiopathic hypersomnia. We eagerly anticipate the results of these trials in the coming months.

Dr Claudia Harper, the Woolcock Sleep Team’s research dietitian, has been integral to the success of a programme of research evaluating new incretin-based anti-obesity drugs to treat obstructive sleep apnea. She successfully recruited 17 participants over three months and supported them on their weight loss journey for over 12 months in the recently published SURMOUNT-OSA trial. Claudia now manages patients currently enrolled in other incretin-based trials, with some patients having life-changing improvements in their sleep and general health.

VOLUNTEERS ARE VITAL

The Woolcock Sleep Trials Team is made up of a dedicated group of medical doctors, clinical trial coordinators and research assistants who work tirelessly together to deliver these successes. This team is made up of some quiet achievers, who turn up with a smile (sometimes at unsociable hours) and get the job done every single day and they should be very proud of their hard work.

At the heart of all clinical research activities performed at the Woolcock are the patients who volunteer their time to participate in trials that lead to medical advances for the greater good. The Woolcock Sleep Trials Team would like to acknowledge and thank the patients and volunteers for everything they do.

Dr Julia Chapman, Clinical Trials Lead – Strategy and Research Development

Find out more

• International Clinical Trials Day 2025
• Our Sleep and Circadian Research group
• Volunteer for Research at the Woolcock