GLP-1 Peptide Atlas, by Delfa

RecruitingPhase 2

Phase II Clinical Trial to Evaluate the Efficacy and Safety of NV01-A02 in Children With Autism Spectrum Disorder

A Multi-center, Randomized, Double-blind, Placebo-controlled, Therapeutic Exploratory Phase II Clinical Trial to Evaluate the Efficacy and Safety of NV01-A02 in Children With Autism Spectrum Disorder

Lead sponsor

Neuroventi Inc.

Asset

Petrelintide

Subcutaneous · Amylin analog

Listed sites

Recruiting sites

Enrollment

105

estimated

Study population

—

Key I/E criterion

•Age 6-15

Primary endpoint

•The composite scores of the major domains of the Korean Vineland Adaptive

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06951854

Org study IDNV01-A02

Timeline

Milestones

Study start2025-04-01actual

Study first posted2025-04-30actual

Last update posted2025-04-30actual

Primary completion2025-09-01estimated

Study completion2026-12-01estimated

Assets

Investigational agents

Petrelintide

Eligibility

Who can enroll

Minimum age6 Years

Maximum age15 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (1)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Other clinical outcomes

1 endpoint

Primary/protocol endpoint

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, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.