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

Inclusion Criteria:

1. Has degenerative disc disease of L3-S1 with low back pain, with or without a historyof radiating leg or buttock pain, paresthesia, numbness or weakness secondary toradiculopathy of the corresponding spinal segment;

2. Has radiographic evidence (e.g., X-ray and CT/magnetic resonance imaging MRI) ofdegenerative disc disease;

3. Adults ≥ 18 and ≤ 80 years of age and skeletally mature at the time of surgery;

4. Plan to undergo a single-level lumbar interbody fusion;

5. Preoperative ODI score ≥ 30;

6. Has not respond to conservative treatment (e.g, bed rest, physical therapy, drugs,local injections, manipulation and other non-surgical treatments) for a period of atleast 3 months;

7. Willing and able to comply with the protocol and able to understand and sign thesubject's informed consent form (ICF) ;

8. Female subjects of child-bearing potential must agree to use a highly effectivemethod of birth control during the study and for 1 year after the administration ofinvestigational drug, and must have a negative pregnancy test prior to therandomization.

Exclusion Criteria:

1. Has undergone other decompression, fusion, and/or other non-fusion spinal surgery atthe spinal segment intended to undergo the surgery prior to the screening (exceptfor transforaminal endoscopic discectomy);

2. Known other significant lumbar instability;

3. Lumbar scoliosis > 30 degrees (evaluated by investigators);

4. Presence of active malignancy or prior history of malignancy;

5. Overt or active infection, either local to surgical space or systemic;

6. Patients with a dual-energy X-ray absorption (DXA) total hip T-score ≤ -3.0;

7. Body weight index (BMI) <18.5 kg/m2 or BMI > 35 kg/m2;

8. Have received other treatments affecting fusion surgery, such as radiotherapy nearthe surgical site;

9. Presence of other co-morbidities of the spine or upper/lower extremities that mayaffect the investigator's assessment of the lumbosacral nervous system and/or pain;

10. Presence of mental disease or psychiatric condition that interferes with thepatient's self-assessment of function, pain, or quality of life;

11. History of progressive osseous heteroplasia or fibrodysplasia ossificansprogressiva;

12. Known hypersensitivity or allergy to bone morphogenetic protein (BMP) products ortheir excipient; and/or instrumentation materials in surgery, e.g., titanium,titanium alloy, cobalt chrome, cobalt chrome alloy, or polyetheretherketone (PEEK);

13. Pregnant or lactating women; or plan to become pregnant within 1 year following thestudy surgery.

14. Other conditions that, in the opinion of the investigator, would interfere with thesubject's ability to comply with the protocol, and other conditions that will makethe subject inappropriate for participation in the study as judged by theinvestigator.