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Evaluating ALKS 2680 for Narcolepsy Type 2

A Phase 2, Parallel-Group, Dose-Range-Finding Study With Randomized Double-Blind Treatment and Open-Label Periods to Evaluate the Safety and Efficacy of ALKS 2680 in Subjects With Narcolepsy Type 2

PHASE2 · Alkermes, Inc. · NCT06555783

This study is testing a new medication called ALKS 2680 to see if it can help adults with narcolepsy type 2 feel less sleepy during the day.

Quick facts

PhasePHASE2
Study typeInterventional
Enrollment80 (estimated)
Ages18 Years to 70 Years
SexAll
SponsorAlkermes, Inc. (industry)
Locations45 sites (Little Rock, Arkansas and 44 other locations)
Trial IDNCT06555783 on ClinicalTrials.gov

What this trial studies

This study aims to assess the safety and effectiveness of ALKS 2680, an orexin-2 receptor agonist, in reducing excessive daytime sleepiness in adults diagnosed with narcolepsy type 2. Participants will receive either ALKS 2680 or a placebo in a controlled setting. The study will involve monitoring participants' responses over a specified period, with a focus on their sleepiness levels and overall safety of the medication. The goal is to determine if ALKS 2680 can provide a meaningful improvement in managing symptoms of narcolepsy type 2.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-70 with a confirmed diagnosis of narcolepsy type 2 and residual excessive daytime sleepiness.

Not a fit: Patients with significant comorbid conditions or those currently pregnant or breastfeeding may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce daytime sleepiness for patients with narcolepsy type 2, improving their quality of life.

How similar studies have performed: While this approach is novel in the context of narcolepsy type 2, similar studies with orexin receptor agonists have shown promise in related conditions.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 18-70 years of age
* Has a BMI ≥18 and ≤40 kg/m2
* Meets the diagnostic criteria of Narcolepsy type 2 according to ICSD-3-TR guidelines.

Additionally, meets the following criteria:

* Has residual excessive daytime sleepiness
* Is willing and able to discontinue any medications prescribed for the management of narcolepsy symptoms for at least 14 days and for the duration of study
* Is willing to adhere to additional protocol requirements

Exclusion Criteria:

* Significant comorbid medical conditions, including other sleep, cardiovascular, psychiatric, hepatic or other disorders may be exclusionary; eligibility will be determined on an individual basis by the study investigator
* Is currently pregnant, breastfeeding, or planning to become pregnant during the study
* Is currently enrolled in another clinical study (other than the parent study) or used any investigational drug or device within 30 days prior to Screening

Where this trial is running

Little Rock, Arkansas and 44 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 →

Conditions: Narcolepsy Type 2, Narcolepsy, NT2, Orexin-2 receptor agonist, Sleep, Sleep disorder, Excessive daytime sleepiness

Last reviewed 2026-05-15 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.