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NCT04551482 · ClinicalTrials.gov registry record · Phase 2
Oxytocin for Weight Loss in Adolescents
A Phase 2 study of Obesity, Adolescent and Oxytocin, sponsored by Massachusetts General Hospital.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 75
- Enrollment target
- 1
- Study location
NCT04551482: Recruiting Phase 2 study of Obesity, Adolescent and Oxytocin, sponsored by Massachusetts General Hospital.
NCT04551482 is a Phase 2 study of Obesity, Adolescent and Oxytocin that is actively recruiting participants, run by Massachusetts General Hospital. The registered enrollment target is 75 participants, below the 231-participant average among 6 other Obesity, Adolescent trials with a reported enrollment target (68% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04551482, a Phase 2 study of Obesity, Adolescent and Oxytocin, is actively recruiting participants, sponsored by Massachusetts General Hospital.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 75 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a randomized, double blind, placebo-controlled study of the effects of intranasal oxytocin in youths with obesity, ages 12-18 years old. Subjects will be randomized to receive intranasal oxytocin or placebo (1 spray per nostril, 4 times per day) for 12 weeks. Study visits include screening to determine eligibility, 2-part main study visits at baseline, week 8, and week 12, and safety check-in visits at weeks 1, and 4; phone calls at weeks 2, 6, and 10, with a safety follow-up visit 6 weeks after the last dose of study drug. Study procedures include appetite, behavioral, metabolic, and endocrine assessments.
Primary Outcome
Mean difference in BMI between Oxytocin and Placebo group after 12 weeks of treatment. BMI will be calculated as weight/height2
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Oxytocin nasal spray
Study Locations (1)
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2021-07-28 |
| Est. Completion | 2027-03-31 |
| Phase | Phase 2 |
What NCT04551482 shows while recruiting
NCT04551482 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 231-participant average among 6 other Obesity, Adolescent trials with a reported enrollment target (68% lower).
The record links to 2 conditions, with Obesity, Adolescent appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04551482 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT04551482 about?
NCT04551482 is a clinical study titled "Oxytocin for Weight Loss in Adolescents". This is a randomized, double blind, placebo-controlled study of the effects of intranasal oxytocin in youths with obesity, ages 12-18 years old. Subjects will be randomized to receive intranasal oxytocin or placebo (1 spray per nostril, 4 times per day) for 12 weeks. Study visits include screening t...
What is the current status of trial NCT04551482?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 75 participants. The study started on 2021-07-28. Estimated completion is 2027-03-31.
What conditions does trial NCT04551482 study?
This clinical trial studies the following conditions: Obesity, Adolescent, Oxytocin.
What interventions are being tested in trial NCT04551482?
The interventions under investigation include: Placebo (DRUG), Oxytocin nasal spray (DRUG).
Who is sponsoring clinical trial NCT04551482?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04551482 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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