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

NCT07799532 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-09-02

No results posted yet for this study

Summary

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.

Conditions

  • Chronic Spinal Cord Injury

Interventions

DRUG

NVG-291

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.

DRUG

Placebo

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.

Sponsors & Collaborators

  • NervGen Pharma

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-23
Primary Completion
2027-07-14
Completion
2027-12-14
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07799532 on ClinicalTrials.gov