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NCT06173531 · ClinicalTrials.gov registry record · Phase 3

Study of Carbetocin Nasal Spray for the Treatment of Hyperphagia in Prader-Willi Syndrome

A Phase 3 study of Hyperphagia in Prader-Willi Syndrome, sponsored by ACADIA Pharmaceuticals.

Active
Registry status
Phase 3
Development phase
170
Enrollment target
20
Study locations

NCT06173531: Active Phase 3 study of Hyperphagia in Prader-Willi Syndrome, sponsored by ACADIA Pharmaceuticals.

NCT06173531 is a Phase 3 study of Hyperphagia in Prader-Willi Syndrome that is active but no longer recruiting, run by ACADIA Pharmaceuticals. The registered enrollment target is 170 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (78% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06173531, a Phase 3 study of Hyperphagia in Prader-Willi Syndrome, is active but no longer recruiting, sponsored by ACADIA Pharmaceuticals.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
170 participants
Enrollment target
20
Study locations

Study Summary

12-week, randomized, double-blind, placebo-controlled, parallel-group study of carbetocin nasal spray for the treatment of hyperphagia in Prader-Willi syndrome (PWS)

Primary Outcome

The HQ-CT is a nine-item questionnaire designed to be completed by caregivers of subjects with PWS. It is a revision of the 11-item HPWSQ-R and has been further validated. The Foundation for Prader-Willi Research has made the HQ-CT available for clinical studies in PWS, and it is the consensus instrument within the PWS research community for measuring observable behaviors that stem from subjects' excessive drive to eat. The HQ-CT should be completed by the same caregiver throughout the study. T

Interventions

  • DRUG Placebo
  • DRUG Carbetocin

Study Locations (20)

California

  • University of California Irvine - Orange
  • Stanford University School of Medicine - Palo Alto
  • Rady Children's Hospital San Diego - San Diego

Missouri

  • Children's Mercy Hospital - Kansas City
  • SSM Health/Saint Louis University - St Louis

Texas

  • Cook Children's Health Care System - Fort Worth
  • Christus Children's - San Antonio

Alabama

  • Children's of Alabama - Birmingham

Arizona

  • Phoenix Children's Hospital - Phoenix

Colorado

  • Children's Hospital Colorado - Aurora

Illinois

  • Ann & Robert H. Lurie Children's Hospital of Chicago - Chicago

Iowa

  • University of Iowa - Iowa City

Trial Details

FieldValue
Enrollment Target 170 participants
Start Date 2023-11-27
Est. Completion 2025-11
Phase Phase 3
ACADIA Pharmaceuticals

35 total trials

What the registry record for NCT06173531 still lists

NCT06173531 is an interventional study that assigns participants to a tested intervention. The registered 170 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (78% lower).

The record links to 1 condition, with Hyperphagia in Prader-Willi Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT06173531 names 20 study sites across 16 states, led by California, Missouri, Texas.

Frequently Asked Questions

What is clinical trial NCT06173531 about?

NCT06173531 is a clinical study titled "Study of Carbetocin Nasal Spray for the Treatment of Hyperphagia in Prader-Willi Syndrome". 12-week, randomized, double-blind, placebo-controlled, parallel-group study of carbetocin nasal spray for the treatment of hyperphagia in Prader-Willi syndrome (PWS)

What is the current status of trial NCT06173531?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 170 participants. The study started on 2023-11-27. Estimated completion is 2025-11.

What conditions does trial NCT06173531 study?

This clinical trial studies the following conditions: Hyperphagia in Prader-Willi Syndrome.

What interventions are being tested in trial NCT06173531?

The interventions under investigation include: Placebo (DRUG), Carbetocin (DRUG).

Who is sponsoring clinical trial NCT06173531?

This trial is sponsored by ACADIA Pharmaceuticals, which has 35 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06173531 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Colorado, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT06173531's enrollment target sits among peer trials

170 1453rd of 2000 higher than 542 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06173531, the US trial registry maintained by the National Library of Medicine. NCT06173531 (mid enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.