Evaluation of Psilocybin (TRP-8802) to Decrease Hyperphagia

• Status: Not yet recruiting
• Trial end date: 2023-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: TRYP Therapeutics
• Treatments: Psilocybin

Criteria

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.