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Evaluation of Psilocybin (TRP-8802) to Decrease Hyperphagia

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ClinicalTrials.gov Identifier: NCT05035927
Recruitment Status : Not yet recruiting
First Posted : September 5, 2021
Last Update Posted : September 5, 2021
Sponsor:
Information provided by (Responsible Party):
TRYP Therapeutics

Tracking Information
First Submitted Date  ICMJE August 24, 2021
First Posted Date  ICMJE September 5, 2021
Last Update Posted Date September 5, 2021
Estimated Study Start Date  ICMJE October 2021
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 1, 2021)
  • Body Mass Index [ Time Frame: 8 weeks following the second dose ]
    Patient's weight in kilograms divided by the square of height in meters. Patient will be weighed on a scale and measured with a stadiometer
  • Clinical Global Impression-Improvement (CGI-I) [ Time Frame: 8 weeks following the second dose ]
    The Clinician's overall impression of a patient's condition (CGI-Improvement, CGI-I, rated 1-7 from "normal" to "among the most extremely ill" and change over the duration of the study.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Psilocybin (TRP-8802) to Decrease Hyperphagia
Official Title  ICMJE A Phase 2a Evaluation of Psilocybin (TRP-8802) Administration in Concert With Psychotherapy to Decrease Hyperphagia in Patients With Overeating Disorders
Brief Summary This is a single-center phase 2a open-label study to assess the efficacy and safety of a dose of psilocybin in subjects with hyperphagia resulting in overeating during both dosing sessions. Subjects will undergo screening, preparation therapy sessions, dosing, integration therapy sessions, and follow-up for 24 weeks following the second of 2 doses. The total participation in the study will be up to 7 months. The study will assess change from baseline in body mass index (BMI). Safety will be assessed during dosing sessions and over a 24 week follow-up period.
Detailed Description

The primary objectives of this study are to:

  1. Document the preliminary clinical activity of TRYP-8802 in conjunction with psychotherapy in subjects with overeating disorders including but not limited to hypothalamic obesity, binge-eating disorder, and Prader-Willi Syndrome, as assessed by maximum change from baseline (CFB) in body mass index (BMI) through 8 weeks following the second of 2 doses.
  2. Assess the safety of TRYP-8802 under the conditions of this study, both during the 2 TRYP-8802 dosing sessions and through 24 weeks following the second of 2 doses.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hyperphagia
Intervention  ICMJE
  • Drug: TRYP-0082
    TRYP-0082 will be administered in conjunction with psychotherapy in subjects with overeating disorders including but not limited to hypothalamic obesity, binge-eating disorder, and Prader-Willi Syndrome, as assessed by maximum change from baseline in body mass index at 8 weeks following the second of 2 doses. Two oral doses of psilocybin will be administered two weeks apart, ±1 day, at Week 2 and Week 4 visit. The first dose will be 25 mg. The second dose will be determined by the Safety Review Committee (SRC) based upon combined results of safety, the MEQ30 and MRS from the first dose, patient consent, and input from the PI and Monitors. The second dose may be the same or higher than the initial dose, with an allowable increase to 0.45 mg/kg (rounded to the nearest 5 mg increment), not to exceed an absolute maximum of 50 mg. Oral psilocybin will be provided in 5 and 25 mg capsules to achieve the desired dose.
    Other Name: Psilocybin
  • Behavioral: Psychotherapy
    TRYP-0082 will be administered in conjunction with psychotherapy in subjects with overeating disorders including but not limited to hypothalamic obesity, binge-eating disorder, and Prader-Willi Syndrome, as assessed by maximum change from baseline in body mass index at 8 weeks following the second of 2 doses. Two oral doses of psilocybin will be administered two weeks apart, ±1 day, at Week 2 and Week 4 visit. The first dose will be 25 mg. The second dose will be determined by the Safety Review Committee (SRC) based upon combined results of safety, the MEQ30 and MRS from the first dose, patient consent, and input from the PI and Monitors. The second dose may be the same or higher than the initial dose, with an allowable increase to 0.45 mg/kg (rounded to the nearest 5 mg increment), not to exceed an absolute maximum of 50 mg. Oral psilocybin will be provided in 5 and 25 mg capsules to achieve the desired dose.
Study Arms  ICMJE Experimental: Open Label Oral Psilocybin
Interventions:
  • Drug: TRYP-0082
  • Behavioral: Psychotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: September 1, 2021)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2023
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Clinically defined overeating disorder that includes but is not limited to hypothalamic obesity, binge-eating disorder and Prader-Willi syndrome, and the Principal Investigator (PI) believes the subject is a good candidate for this study.
  2. If the overeating disorder is due to hypothalamic obesity, then ≥ 6 months post-surgical or radiation or chemotherapy treatment for primary craniopharyngiomas or other suprasellar tumors.
  3. Age ≥16 and ≤64 years.
  4. Provision of signed and dated informed consent form or parental consent for those under the age of 18.
  5. Stated willingness to comply with all study procedures and availability for the duration of the study.
  6. Ability to take oral medication and be willing to adhere to the study regimen.
  7. Medically stable in the judgment of the Principal Investigator, as determined by screening medical, physical examination, electrocardiogram (ECG), and routine laboratory tests including blood and urinalysis.
  8. For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 4 weeks following the second of 2 doses of TRYP-8802.
  9. For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner through 90 days post-second dose.
  10. Agree to consume approximately the same amount of caffeine-containing beverage (e.g., coffee, tea) that he/she consumes on a usual morning, before arriving at the research unit on the mornings of drug session days. If the participant does not routinely consume caffeinated beverages, he/she must agree not to do so on session days.
  11. Agree to refrain from using any psychoactive drugs, including alcoholic beverages from a minimum of 1 week prior to 1st drug administration.
  12. Agree that for one week before each drug session, he/she will refrain from taking any nonprescription medication, nutritional supplement, or herbal supplement, or PRN prescription medication except when approved by the study investigators. Exceptions will be evaluated by the study investigators and will include acetaminophen, non-steroidal anti-inflammatory drugs, and common doses of vitamins and minerals.

Exclusion Criteria:

To participate in this study, subjects must not meet any of the following criteria:

  1. Significant suicide risk as defined by either suicidal ideation as endorsed on items 4 or 5 on the C-SSRS within the past year, at Screening or at Baseline; or suicidal behaviors within the past year; clinical assessment of significant suicidal risk during subject interview.
  2. Participation in another concurrent clinical study or within the preceding month.
  3. Women who are pregnant or who intend to become pregnant during the study or who are currently nursing.
  4. Have any of the following cardiovascular conditions: uncontrolled hypertension, coronary artery disease, congenital long QT syndrome, cardiac hypertrophy, cardiac ischemia, congestive heart failure, prior myocardial infarction, tachycardia, artificial heart valve, a clinically significant screening ECG abnormality, or any other significant cardiovascular condition.
  5. Presence of a gastrointestinal disease that could interfere with absorption of orally-administered TRYP-8802.
  6. Have epilepsy.
  7. Meet DSM-5 criteria for schizophrenia spectrum or other psychotic disorders, including major depressive disorder with psychotic features, or Bipolar I or Bipolar II Disorder.
  8. Family history of psychosis.
  9. Meet DSM-5 criteria for a moderate or severe alcohol or drug use disorder.
  10. Positive urine drug screen, alcohol breath test, or urine cotinine test at screening. A repeat test can be conducted at screening or Day -1 at the discretion of the Principal Investigator or delegate.
  11. Prior adverse effects from psilocybin.
  12. Currently taking on a regular (e.g., daily) basis any medications having a primary centrally-acting serotonergic effect, including SSRIs and MAOIs. For individuals who have intermittent or PRN use of such medications, psilocybin sessions will not be conducted until at least 5 half-lives of the agent have elapsed after the last dose.
  13. fMRI subjects: Contraindications to fMRI procedures, per institutional policy.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 64 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jim Gilligan, PhD (833) 811-8797 jgilligan@tryptherapeutics.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05035927
Other Study ID Numbers  ICMJE TRYP-001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party TRYP Therapeutics
Study Sponsor  ICMJE TRYP Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jennifer Miller, MD University of Florida
PRS Account TRYP Therapeutics
Verification Date September 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP