DRUG
Drug: NV01-A02
NV01-A02 will be administered orally at a different dose once daily for 8 weeks. The formulation is a white, film-coated tablet, designed for use in patients with mild to moderate cognitive impairment.
Status
Recruiting
Phase
Phase 2
Enrollment
105
Locations
1
Results
Not posted
Publications
0
Study summary
This is a multicenter, randomized, double-blind, placebo-controlled, therapeutic exploratory Phase 2 clinical trial designed to evaluate the efficacy and safety of NV01-A02 in pediatric participants diagnosed with Autism Spectrum Disorder (ASD).
Interventions
DRUG
NV01-A02 will be administered orally at a different dose once daily for 8 weeks. The formulation is a white, film-coated tablet, designed for use in patients with mild to moderate cognitive impairment.
DRUG
ZP8396 is a matching placebo tablet administered orally once daily for 8 weeks. The placebo is identical in appearance to NV01-A02 but contains no active ingredient.
Timeline
First posted
Apr 30, 2025
Study start
Apr 1, 2025
Primary completion
Sep 1, 2025
Study completion
Dec 1, 2026
Results posted
Not reported
Registry updated
Apr 30, 2025
Outcomes
Change from baseline in the composite scores of the major domains of the Korean Vineland Adaptive Behavior Scales-II (K-Vineland-II) at Week 8 after administration.
Time frame · From enrollment to the end of treatment at 8 weeks
Change from baseline in the composite scores of the major domains of the Korean Vineland Adaptive Behavior Scales-II (K-Vineland-II) at Week 8 after administration.\* For children under 7 years of age, the composite score refers to the standard scores of all four major domains: Communication, Daily Living Skills, Socialization, and Motor Skills. For children aged 7 years and older, the composite score refers to the standard scores of the three domains excluding Motor Skills: Communication, Daily Living Skills, and Socialization.
Not reported in the indexed record.
Eligibility
Inclusion Criteria: \- Inclusion Criteria: Children aged 6 to 15 years (inclusive) as of the date of written consent Individuals who meet all the diagnostic criteria for Autism Spectrum Disorder (ASD) as outlined in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) DSM-5 Diagnostic Criteria for Autism Spectrum Disorder (ASD): * Persistent deficits in social communication and social interaction across multiple contexts, as manifested by all of the following: A. Deficits in social-emotional reciprocity B. Deficits in nonverbal communicative behaviors used for social interaction C. Deficits in developing, maintaining, and understanding relationships ② Restricted, repetitive patterns of behavior, interests, or activities, as manifested by at least two of the following: A. Stereotyped or repetitive motor movements, use of objects, or speech B. Insistence on sameness, inflexible adherence to routines, or ritualized patterns of verbal or nonverbal behavior C. Highly restricted, fixated interests that are abnormal in intensity or focus D. Hyper- or hyporeactivity to sensory input or unusual interest in sensory aspects of the environment ③ Symptoms must be present in the early developmental period (but may not become fully manifest until social demands exceed limited capacities, or may be masked by learned strategies later in life) Exclusion Criteria: * Individuals weighing less than 16 kg or more than 70 kg Individuals identified during screening with any of the following medical histories, comorbid conditions, or surgical histories: * Severe psychiatric disorders (other than autism spectrum disorder) that may affect participation in the clinical trial * History of organic brain disease, neurological disorders, or epilepsy/seizures that are not fully controlled by medication or non-pharmacologic surgical treatment (Note: Participants with a history of simple febrile seizures may be included at the investigator's discretion) * Severe peripheral arterial disease or coronary insufficiency * Presence or history of psychotic symptoms such as delusions or hallucinations (e.g., worsening or recurrence of psychiatric illness) * Gastrointestinal diseases (e.g., active peptic ulcers) or history of surgery that may affect absorption of the investigational medicinal product (Note: Participants with a history of simple appendectomy or hernia surgery may be included) * Individuals displaying serious self-injurious or aggressive behavior requiring medical intervention during the screening period, as determined by the investigator * Individuals with sensory abnormalities such as congenital hearing loss
Study locations
South Korea. Showing up to 24 locations stored in the fast local snapshot.
Neuroventi
Seoul, Seoul, South Korea
Publications
No PMID-linked publications were present in this registry snapshot.
Related trials
Hoffmann-La Roche · Obesity or Overweight
Phase 2
Not yet recruiting
486
2026-07
Zealand Pharma · Impaired Hepatic Function
Phase 1
Recruiting
36
2026-07
Zealand Pharma · Obesity & Overweight
Phase 1
Completed
48
2026-04
Zealand Pharma · Obesity
Phase 2
Completed
493
2026-03
Zealand Pharma · Renal Impairment
Phase 1
Completed
39
2026-01
Zealand Pharma · Overweight · Type 2 Diabetes
Phase 2
Active, not recruiting
221
2026-01
Zealand Pharma · Overweight · Healthy Volunteers
Phase 1
Completed
68
2024-06
Zealand Pharma · Overweight · Healthy Volunteers
Phase 1
Completed
64
2023-01
Related PeptideStat pages
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.