A Trial Investigating the Efficacy and Safety of NVG-291 in Subjects With Chronic Spinal Cord Injury

Conditions

• Chronic Spinal Cord Injury

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• NVG-291 — DRUG
  NVG-291 is an investigational peptide therapeutic administered by subcutaneous injection. Participants randomized to the experimental arm will receive NVG-291 once daily for 12 weeks. NVG-291 is designed to promote nervous system repair and functional recovery following chronic spinal cord injury.
• Placebo — DRUG
  Matching placebo is supplied as a sterile lyophilized formulation matching NVG-291 in appearance and route of administration. Participants randomized to the placebo arm will receive placebo once daily by subcutaneous injection for 12 weeks.

Study Details

The goal of this clinical trial is to learn if NVG-291 can improve function in adults with chronic cervical motor-incomplete spinal cord injury. It will also learn about the safety of NVG-291. The main questions it aims to answer are: * Does NVG-291 improve hand function and daily activities? * What side effects do participants have when taking NVG-291? Researchers will compare NVG-291 to a placebo (a look-alike substance that does not contain NVG-291) to see if NVG-291 improves function in adults with chronic cervical motor-incomplete spinal cord injury. Participants will: * Take NVG-291 or a placebo by injection under the skin (subcutaneous) once daily for 12 weeks. * Attend clinic visits for checkups and safety tests. * Complete tests and questionnaires about hand function, walking, daily activities, and quality of life. * Take part in an interview about changes in their condition, within 14 days after the Week 12 visit.

Key Dates

First listed

Sep 2, 2026

Start date

Sep 23, 2026

Status verified

Aug 2026

Primary completion

Jul 14, 2027

Completion

Dec 14, 2027

Study Design

Enrollment

150 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: NVG-291 Arm
  Participants will receive NVG-291 administered once daily by subcutaneous injection for 12 weeks during the double-blind treatment period. Randomization will occur in a 1:1 ratio and will be stratified by country (United States or Canada) and baseline American Spinal Injury Association (ASIA) Impairment Scale category (C or D).
• Placebo Comparator: Placebo Arm
  Participants will receive placebo administered once daily by subcutaneous injection for 12 weeks during the double-blind treatment period. Randomization will occur in a 1:1 ratio and will be stratified by country (United States or Canada) and baseline American Spinal Injury Association (ASIA) Impairment Scale category (C or D).

Primary Outcome Measure

Efficacy of NVG-291 as measured by change from baseline in combined Graded and Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) Quantitative Prehension (QtP) score [ Time Frame: Baseline to Week 12 ]

Central Contacts

• Study Team
  778 731-1711
  [email protected]
• Adam Rogers MD, Chief Executive Officer, NervGen Pharma

Locations (17)

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