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Also known as ACP-101
Carbetocin · 1 trial · 1 indication
The HQ-CT is a caregiver-reported, 9-item assessment of observable hyperphagia-related behaviors in participants with PWS. The questionnaire is administered to the caregiver by a trained rater using standardized prompts, and the same caregiver is expected to complete the assessment throughout the study whenever possible. Each item is scored from 0 to 4, resulting in a total score ranging from 0 to 36, with higher scores indicating greater severity of hyperphagia. A decrease from baseline reflects improvement, and a reduction of 7.7 points has been identified as a clinically meaningful within-participant improvement.
| Arm | Type | Description |
|---|---|---|
| Carbetocin | EXPERIMENTAL | Carbetocin nasal spray 3.2 mg administered TID |
| Placebo | PLACEBO_COMPARATOR | Matching placebo nasal spray administered TID |
| Name | Type | Description |
|---|---|---|
| Carbetocin | DRUG | Carbetocin nasal spray 3.2 mg administered TID |
| Placebo | DRUG | Matching placebo nasal spray administered TID |
Inclusion Criteria * Male or female participants aged 5 to 30 years * Diagnosis of Prader-Willi syndrome with a documented disease-causing genetic mutation * Evidence of hyperphagia, including increased appetite and decreased satiety with food-seeking behaviors * Meeting minimum severity thresholds...
Carbetocin is being developed for the treatment of hyperphagia in Prader-Willi Syndrome, a condition marked by persistent, excessive appetite and food-seeking behavior. ACADIA Pharmaceuticals is studying a nasal spray formulation of carbetocin for this indication in a Phase 3 clinical program. It is an investigational therapy and is not approved for this use.
Carbetocin targets OXTR, the oxytocin receptor, and acts as an agonist at that receptor. By activating the oxytocin receptor, carbetocin is designed to address hyperphagia in Prader-Willi Syndrome. It is a small molecule administered as a nasal spray in the Phase 3 program being run by ACADIA Pharmaceuticals.
ACADIA Pharmaceuticals Inc., which trades on Nasdaq under the ticker ACAD, is developing carbetocin nasal spray for hyperphagia in Prader-Willi Syndrome. The company is the sponsor of the Phase 3 clinical program evaluating the drug in this indication across sites in the United States, Canada, and several European countries.
Carbetocin is in Phase 3 development for hyperphagia in Prader-Willi Syndrome. The program includes a completed Phase 3 trial, and carbetocin remains an investigational therapy that has not been approved for this indication. ACADIA Pharmaceuticals is the sponsor developing the nasal spray formulation.
Carbetocin has been studied in the Phase 3 trial NCT06173531, titled Study of Carbetocin Nasal Spray for the Treatment of Hyperphagia in Prader-Willi Syndrome. The trial enrolled 175 participants aged 5 years and older across the United States, Canada, France, Germany, Spain, and the United Kingdom, and it is now completed.
The Phase 3 trial NCT06173531 was a randomized, double-blind, placebo-controlled study of carbetocin nasal spray in hyperphagia associated with Prader-Willi Syndrome. It enrolled 175 participants of all sexes, aged 5 years and older, and did not include healthy volunteers. The study is listed as completed and spanned sites in North America and Europe.