A Study of Oral SOM001 as a Safe and Effective Treatment for Adults With Chronic Insomnia in a Randomized, Controlled, Dose-finding Study

A Phase 2a, Multi-center, Randomized, Double-blind, Placebo-controlled, Dose-finding Study to Evaluate the Safety, Tolerability, and Efficacy of Oral SOM001 in Adults With Chronic Insomnia

The goal of this clinical trial is to learn if SOM001 is safe and well tolerated in adults with insomnia. It will also evaluate if it helps to improve sleep. The main questions this trial aims to answer are:

1. Is SOM001 associated with any side-effects
2. Do people tolerate SOM001 well
3. Is SOM001 helpful to improve sleep

Researchers will compare SOM001 to a placebo (a look-alike substance that contains no drug) as well as to 2 other well-established medications that are often used to treat sleep.

Participants will:

1. Take one of the drugs, or placebo for 3 nights each week, for 3 weeks. The drugs will be pre-assigned and change each week.
2. Be asked questions about their sleep and overall health, including mental health
3. Complete tests to evaluate their memory and alertness on the computer
4. Use monitors at night to evaluate their sleep quality and activity.

This will be a virtual study and participants will connect with the study team via video and phone calls for training and check-ups during the study.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Insomnia
• Intervention / Treatment: Drug: Placebo; Drug: SOM001-A; Drug: SOM001-B; Drug: Low Dose Drug A; Drug: High Dose Drug A; Drug: Low Dose Drug B; Drug: High Dose Drug B; Drug: SOM001-C; Drug: SOM001-D

Detailed Description

This clinical trial aims to evaluate if SOM001 is safe and well tolerated, and if it helps to improve sleep in adults with insomnia. Up to 45 adults (ages 18 to 65) will be asked to participate in the study.

The study will be conducted in the participants' home environment and all visits will be remote using phone and video calls.

The study will include 3 main phases:

1. Screening period to evaluate eligibility in the trial. It may include up to 4 visits and testing of sleep monitoring devices at home. If a person is not eligible, this will end their participation in the study. There will be no reimbursement for their time during this screening phase. A person will be deemed eligible if they meet the specific inclusion and exclusion criteria for the study and are willing to be monitored at home for the duration of the study. Eligible participants will be enrolled in the study.
2. Study Intervention period: enrolled participants will be assigned to take the study medications before going to sleep for 3 nights a week, for 3 weeks. The study medications will consist of either SOM001, a placebo, or 2 other medications commonly used to treat insomnia. A different study medication will be given each week. On the nights that they take the study medications, participants will be asked to use monitors to evaluate their activity and sleep. These monitors will require them to use a phone application on their own mobile phones. Information and training on the use of these devices will be given by the research team. In the mornings after waking up, participants will remove the monitors and be asked to complete an online survey regarding their sleep and potential changes in symptoms. They will be also asked to complete an online test of memory and alertness. These morning assessments are expected to take up to 10 minutes to complete. Information from the questionnaires and the sleep monitoring devices used at night will be collected by the research team and used as part of the study. Each week the participants will have virtual visits. The sleep monitoring equipment will be provided to the participants free of charge and must be returned to the research team at the end of this phase.
3. End of Study period will consist of a final virtual meeting with the research team to review their participation and issue their reimbursement for participating in the study.

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Patricia Tolete; Phone Number: 347-495-4416; Email: patricia.tolete@phifundvc.com

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • 4 East 70th Street, 9a
      • Contact: Patricia Tolete; Phone Number: 347-49504416; Email: patricia.tolete@phifundvc.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Willing and able to provide informed consent prior to initiation of study procedures
2. Males and females, ages 18-65 years (inclusive)
3. Willing to use a highly effective method of contraception for the duration of the study (see Section 9.8.1) for more details on acceptable forms of contraceptives)
4. Can follow directions and comply with schedule of visits
5. Has a valid email address
6. Has access to a mobile device and Wi-Fi and is willing to download required applications on their own device
7. Has a computer with a keyboard for study questionnaires
8. Diagnosis of chronic insomnia based on DSM-5-TR criteria at least three nights per week and for at least 3 months
9. Modified Insomnia Severity Index (ISI) of 7 or higher
10. Willing to keep a regular sleep schedule and not deviate the sleep period by more than 90 minutes during study participation
11. Have not used a hypnotic prescription medication in the 4 weeks preceding study enrollment or a supplement or OTC sleep aid (e.g., melatonin) for 2 weeks before study enrollment

Exclusion Criteria:

1. Non-English-speaking participants
2. Participants currently participating in any other clinical trial for insomnia or requiring the use of experimental drugs
3. Untreated sleep apnea (defined as overall Apnea-Hypopnea Index [AHI] >15 within the preceding 12 months or a STOP-BANG score over 5 within 3 months of enrollment)
4. Current diagnosis or symptoms of restless legs syndrome or significant periodic limb movements (index over 15/h) in sleep
5. Suicide thoughts, behavior, and/or attempt in past 5 years
6. Underlying active diagnosis of circadian rhythm sleep-wake disorder (including current shift work) or underlying active diagnosis of parasomnia
7. At Screening, a score greater than 0 on the C-SSRS
8. Use of alcoholic drinks more frequently than one drink per day and more than 3 times a week
9. Use of coffee or caffeinated beverages within 6 hours of bedtime
10. Changes in use of nicotine or vaping within one month prior to randomization (use must be stable)
11. Use of cannabidiol (CBD)-containing or other cannabis-based products (e.g., tetrahydrocannabinol [THC]) within 2 weeks of study enrollment
12. Clinically unstable cardiac arrhythmia
13. Cardiovascular revascularization procedure within 3 months
14. History of an epileptic seizure in past 5 years
15. Diagnosis of dementia or neurodegenerative disease
16. Glaucoma
17. Participants undergoing peritoneal dialysis or hemodialysis
18. Active kidney or liver disease, including an estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m², Child-Pugh score ≥7, or clinical evidence of ascites or hepatic encephalopathy. The most recent eligible laboratory results must have been obtained within 30 days prior to enrollment, defined as the pre-randomization visit (e.g., Day -14 to -5).
19. Current diagnosis of active malignancy or oncological disease with poor prognosis based on clinical assessment
20. Current or planned chemotherapy treatment in the next 3 months
21. Pregnancy, within 4 months post-partum, actively nursing, or planning to conceive within 3 months of enrollment
22. Acute or chronic pain secondary to a rheumatic disease or another untreated chronic disease interfering with sleep
23. Mental or physical incapacities that interfere with activities of daily living (ADLs), impeding participation in interviews, or overnight sleep monitoring
24. Participants with any clinical signs or symptoms of active infection or inflammatory conditions including upper respiratory infection that may impact sleep
25. Active psychiatric disorder requiring medication therapy or one in which medication was recommended by a provider but declined by the participant (e.g., major depressive or bipolar disorder in active treatment with medication or where a physician has recommended medical therapy in past year)
26. Severe psychiatric disorder; or diagnosis of major depressive disorder in the clinical records in past 5 years
27. Alcohol or drug abuse during the last year (DSM-5-TR criteria)
28. Use of anticoagulant medication except for low-dose aspirin (e.g., 81 mg per day)
29. Current, regular use of a medication that could interfere with sleep (e.g. antidepressants, steroids/glucocorticoids, opioid pain killers, sedating antihistamine). Allowed pain medications include acetaminophen and ibuprofen.
30. Current use of an antidepressant or anti-psychotic medication, including monoamine oxidase inhibitors
31. Current use of strong CYP3A4 inhibitors or inducers (Appendix J)
32. Active medical problem which required hospitalization or emergency care in the past 6 months
33. Hospital admission or outpatient surgical procedure within 3 months of study enrollment
34. Any other condition that, in the Investigator's opinion, would pose a health risk to the participant if enrolled or could interfere with evaluation of the investigational product or interpretation of study results

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo
Experimental: SOM001-A and SOM001-B	Drug: SOM001-A; SOM001-A; Drug: SOM001-B; SOM001-B
Active Comparator: Drug A	Drug: Low Dose Drug A; Low Dose Drug A; Drug: High Dose Drug A; High Dose Drug A
Active Comparator: Drug B	Drug: Low Dose Drug B; Low Dose Drug B; Drug: High Dose Drug B; High Dose Drug B
Experimental: SOM001-C and SOM001-D	Drug: SOM001-C; SOM001-C; Drug: SOM001-D; SOM001-D

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants with treatment-related adverse events at 3 weeks after SOM001 intervention as compared to placebo	3 weeks
Incidence, severity, and relationship of adverse events (AEs) after SOM001 intervention as compared to placebo	3 weeks
Incidence of serious adverse events (SAEs) after SOM001 intervention as compared to placebo	3 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Changes in Wake After Sleep Onset (WASO) after SOM001 intervention as compared to placebo	3 weeks
Changes in Latency to Persistent Sleep (LPS) after SOM001 intervention as compared to placebo	3 weeks
Changes in Total Sleep Time (TST) after SOM001 intervention as compared to placebo	3 weeks

Other Outcome Measures

Outcome Measure	Time Frame
Changes in Karolinska Sleepiness Scale (KSS) score after SOM001 intervention as compared to placebo	3 weeks
Changes in Patient Global Impression-Severity (PGI-S) score after SOM001 intervention as compared to placebo	3 weeks
Changes in cognitive function and alertness by Cognitive Test - Symbol Digit Coding (SDC) after SOM001 intervention as compared to placebo	3 weeks
Changes in WASO after SOM001 intervention as compared to Drug A	3 weeks
Changes in LPS after SOM001 intervention as compared to Drug A	3 weeks
Changes in TST after SOM001 intervention as compared to Drug A	3 weeks
Changes in WASO after SOM001 intervention as compared to Drug B	3 weeks
Changes in LPS after SOM001 intervention as compared to Drug B	3 weeks
Changes in TST after SOM001 intervention as compared to Drug B	3 weeks

Collaborators and Investigators

• Sponsor: Somnum Pharma Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2027
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): February 1, 2028

Study Registration Dates

• First Submitted: October 30, 2026
• First Submitted That Met QC Criteria: October 30, 2026
• First Posted (Actual): November 5, 2026

Study Record Updates

• Last Update Posted (Actual): November 5, 2026
• Last Update Submitted That Met QC Criteria: October 30, 2026
• Last Verified: October 1, 2026

More Information

Terms related to this study

• Keywords: insomnia; chronic insomnia
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: SOM001-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No