Global Phase 2b Trial Launching of Tesomet in Easing Hyperphagia
“The initiation of this Phase 2b clinical trial of Tesomet in Prader-Willi syndrome follows our recent initiation of a Phase 2b clinical trial of Tesomet in hypothalamic obesity — two serious diseases with high unmet need,” Rudolf Baumgartner, MD, Saniona’s chief medical officer and head of clinical development, said in a press release.
The trial (NCT05198362) aims to enroll up to 120 people with genetically confirmed PWS. It initially will enroll adults ages 18 to 65, then — following safety analyses — may expand to include adolescents starting at 13 years old. It is opening at multiple sites worldwide, including in the U.S., Europe, New Zealand, and Australia.
One site is currently listed and others are expected; information, including who to contact, is here.
During the study’s first 16 weeks (about four months), participants will be randomly assigned to one of three oral doses of Tesomet or to a placebo, given once daily.
Its main goal is to assess the effect of treatment on hyperphagia — uncontrollable hunger — as measured by the Hyperphagia Questionnaire for Clinical Trials (HQ-CT), a caregiver-reported survey of food-seeking behavior, like sneaking food or talking about food, that is commonly used in PWS trials.
“Currently, there are no approved treatments for hyperphagia, the uncontrollable hunger that is one of the most debilitating symptoms of PWS. We are encouraged to see Saniona addressing hyperphagia, and we look forward to working with them to support this clinical trial through education and outreach amongst our community,” said Paige Rivard, CEO of Prader-Willi Syndrome Association USA.
Secondary trial goals will assess changes with Tesomet’s use in body weight, and in caregiver and clinician impressions of overall disease severity and patients’ health.
After its 16 weeks, patients will have the option of enrolling in a 36-week open-label extension. Here, all will be treated with Tesomet at the highest tolerated dose as determined in the main, placebo-controlled trial and monitored for safety and efficacy.
Tesomet is a fixed-dose combination of two compounds, tesofensine and metoprolol, now in a capsule formulation. Tesofensine is designed to increase the activity of three brain signaling molecules or neurotransmitters — specifically serotonin, noradrenaline, and dopamine — to ease hunger cravings. Metoprolol, a medication for high blood pressure and heart failure, is included to minimize the risk of heart-related side effects associated with tesofensine’s use.
Tesomet has been designated an orphan drug by the U.S. Food and Drug Administration. Results of a Phase 2a study (NCT03149445) indicated that the investigational medicine can lessen hyperphagia and promote weight loss in adults and adolescents with PWS.
The combination medicine was developed initially as a tablet. Saniona moved to a capsule formulation to potentially make it easier to swallow and to minimize chewing before it’s swallowed, which can affect treatment efficacy.