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Evaluating TAK-360 for adults with Narcolepsy Type 2

A Randomized, Double-Blinded, Placebo-Controlled, Dose-Finding, Adaptive Trial to Evaluate the Safety, Tolerability, and Efficacy of TAK-360 in Participants With Narcolepsy Without Cataplexy (NT2)

Phase 2 Interventional Takeda · NCT06952699

This study is testing a new medication called TAK-360 to see if it can help adults with Narcolepsy Type 2 stay awake during the day.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment88 (estimated)
Ages18 Years to 70 Years
SexAll
SponsorTakeda Industry-sponsored
Locations30 sites (Redwood City, California and 29 other locations)
Trial IDNCT06952699 on ClinicalTrials.gov

What this trial studies

This study investigates the safety and tolerability of TAK-360, a medication that mimics orexin, in adults diagnosed with Narcolepsy Type 2 (NT2). Participants will be randomly assigned to receive either TAK-360 or a placebo to assess its effectiveness in helping them stay awake during the day. The study aims to determine the appropriate dosage of TAK-360 needed for optimal results. By focusing on NT2, which significantly impacts daily functioning, the research seeks to improve the quality of life for affected individuals.

Who should consider this trial

Good fit: Ideal candidates are adults diagnosed with Narcolepsy Type 2 who meet specific weight and BMI criteria.

Not a fit: Patients with excessive daytime sleepiness due to other medical disorders or significant thyroid disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly enhance daytime alertness and overall quality of life for patients with Narcolepsy Type 2.

How similar studies have performed: Previous studies have shown promise with medications that act like orexin, suggesting potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

1. The participant weighs greater than equal or to (≥)40 kilograms (kg) and has a body mass index (BMI) between 16 and 38 kilograms per meter square (kg/m\^2) \[inclusive\].
2. The participant has a documented, current diagnosis of NT2.

Key Exclusion Criteria:

1. The participant has a current medical disorder associated with excessive daytime sleepiness (EDS) other than NT2.
2. The participant has medically significant thyroid disease.
3. The participant has a history of cancer in the past 5 years. (This exclusion does not apply to participants with carcinoma in situ \[such as basal cell carcinoma\] that has been treated and is stable, or who have been stable without further treatment. These participants may be included after approval by the medical monitor).
4. The participant has any of the following viral infections based on a positive test result: Hepatitis B surface antigen (at screening), hepatitis C virus (HCV) antibody (at screening), human immunodeficiency virus (HIV) antibody/antigen (at screening).
5. The participant has a clinically significant history of head injury or head trauma.
6. The participant has history of epilepsy, seizure, or convulsion (exception for a single febrile seizure in childhood).
7. The participant has a history of cerebral ischemia, transient ischemic attack (\<5 years from screening), intracranial aneurysm, or arteriovenous malformation.

Where this trial is running

Redwood City, California and 29 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Narcolepsy Type 2Narcolepsy without CataplexyNT2TAK-360
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.