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A Phase 3 Study of AGA111 in Patients With Degenerative Disc Disease Undergoing Lumbar Interbody Fusion

NCT06115512 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 412

Last updated 2026-01-28

No results posted yet for this study

Summary

The primary objective of the study is to assess the overall efficacy of a single intervertebral local administration of AGA111 in patients with degenerative disc disease undergoing lumbar interbody fusion.

Conditions

  • Degenerative Disc Disease

Interventions

DRUG

AGA111

AGA111 is locally administered in an ABC carrier at the intervertebral space during the lumbar interbody fusion.

DRUG

Placebo

Placebo is locally administered in an ABC carrier at the intervertebral space during the lumbar interbody fusion.

Sponsors & Collaborators

  • Angitia Biopharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Angitia Medical Director · Angitia Biopharmaceutics Guangzhou Limited

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-12-08
Primary Completion
2025-11-28
Completion
2026-11-30

Countries

  • China

Study Locations

More Related Trials

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 NCT06115512 on ClinicalTrials.gov