Clover Announces Completion of US FDA IND Submission for Second Pivotal Phase 3 Clinical Trial of CBL-514 Injection for Abdominal Fat Reduction
Clover Biopharmaceuticals announced that the second pivotal Phase 3 clinical trial (SUPREME-02, code CBL-0302) for its new drug CBL-514 injection, used for reducing abdominal subcutaneous fat, has completed its Investigational New Drug (IND) submission to the US FDA on April 20, 115 (2026).
📋 Article Processing Timeline
- 📰 Published: April 20, 2026 at 09:00
- 🔍 Collected: April 21, 2026 at 08:00 (23h 0m after Published)
- 🤖 AI Analyzed: April 21, 2026 at 08:11 (11 min after Collected)
1. Date of event: 115/04/20
2. Name or code of new drug being developed: CBL-514
3. Indications:
A. Reduction of subcutaneous fat
B. Improvement of moderate/severe cellulite
C. Treatment of rare disease, Dercum's disease
4. All planned R&D stages:
A. Phase 1 clinical trial: Completed.
B. Phase 2 clinical trial: Multiple Phase 2 trials completed (e.g., CBL-0205); CBL-0206 application submitted to HREC Australia.
C. Phase 3 clinical trial: First pivotal Phase 3 trial (CBL-0301) approved in the US and Canada; second pivotal Phase 3 trial (CBL-0302) application submitted.
D. New Drug Application (NDA): Not yet initiated.
5. Current R&D stage (indicate application submission/approval/rejection, risks and countermeasures if rejected; future business direction and cumulative R&D expenses):
(1) Application submission/approval/rejection/results of human trials (including interim analyses)/other significant events affecting new drug R&D:
Clover's new drug CBL-514 injection for reducing abdominal subcutaneous fat has completed its IND submission to the US FDA today for the second pivotal multi-center Phase 3 clinical trial (SUPREME-02) for New Drug Application (NDA).
This trial will use MRI to measure changes in abdominal subcutaneous fat volume and the Patient Reported-Abdominal Fat Rating Scale (PR-AFRS) to assess improvement in abdominal fat grade as primary efficacy endpoints. It is expected to enroll 320 subjects in the US, Canada, and Australia. The IND application was submitted to the US FDA on April 20, 2026.
A. Clinical trial design introduction (including trial name, objective, phase, drug name, claimed indication, evaluation endpoints, planned enrollment):
a. Trial name:
A Phase 3, randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy, safety, and tolerability of CBL-514 injection in reducing abdominal subcutaneous fat (SUPREME-02).
b. Trial objective: To evaluate the efficacy, safety, and tolerability of CBL-514 injection for reducing abdominal subcutaneous fat.
c. Trial phase: Phase 3 clinical trial
d. Drug name: CBL-514
e. Claimed indication: Reduction of abdominal subcutaneous fat
f. Evaluation endpoints: Primary efficacy endpoints are changes in abdominal subcutaneous fat volume measured by MRI and assessment of abdominal fat grade improvement using PR-AFRS (Patient Report-Abdominal Fat Rating Scale).
g. Planned enrollment: Approximately 320 subjects
B. Statistical results of primary and secondary endpoints (including P-values) and statistical significance (whether statistically significant): Not applicable.
C. If statistical data for a Phase 3 human clinical trial (including interim analysis) is known, please describe the future market entry plan (note: avoid statements requiring financial forecasts for listed companies):
Not applicable.
D. Results from a single clinical trial (including statistical P-values and statistical significance of primary and secondary endpoints) are insufficient to fully reflect the success or failure of future new drug development and market entry. Investors should exercise prudent judgment and invest cautiously.
(2) Risks faced by the company and countermeasures if not approved by the competent authority, if human trial results (including interim analyses) do not achieve statistical significance, or if other significant events affect new drug R&D: Not applicable.
(3) Future business direction if approved by the competent authority, if human trial results (including interim analyses) achieve statistical significance, or if other significant events affect new drug R&D: Under evaluation by the company.
(4) Cumulative R&D expenses invested: To consider future market marketing strategies and protect the rights and interests of the company and investors, disclosure is temporarily withheld.
6. Next planned R&D stage (estimated completion time and obligations):
(1) Estimated completion time: Actual schedule will be adjusted based on clinical trial progress.
(2) Estimated obligations: None.
7. Market status:
Currently, over 80% of fat reduction treatments still use invasive surgical methods, including liposuction and abdominoplasty. Although surgical procedures have significantly more obvious fat reduction efficacy than currently marketed non-surgical fat reduction products, they still carry many apparent side effects and sequelae, and potentially life-threatening severe side effects. Therefore, non-surgical fat reduction products have rapidly emerged in recent years, including cryolipolysis, ultrasonic fat reduction, and fat-reducing injections (ingredients: deoxycholic acid or its salts), etc. However, most current non-surgical fat reduction products have poor efficacy, cannot significantly reduce subcutaneous fat in the treated area, and require more than 12 weeks to show results, accompanied by risks of moderate to severe side effects such as skin necrosis, nerve damage and paralysis, scar tissue, lumps, and paradoxical adipose hyperplasia (paradoxical ad
2. Name or code of new drug being developed: CBL-514
3. Indications:
A. Reduction of subcutaneous fat
B. Improvement of moderate/severe cellulite
C. Treatment of rare disease, Dercum's disease
4. All planned R&D stages:
A. Phase 1 clinical trial: Completed.
B. Phase 2 clinical trial: Multiple Phase 2 trials completed (e.g., CBL-0205); CBL-0206 application submitted to HREC Australia.
C. Phase 3 clinical trial: First pivotal Phase 3 trial (CBL-0301) approved in the US and Canada; second pivotal Phase 3 trial (CBL-0302) application submitted.
D. New Drug Application (NDA): Not yet initiated.
5. Current R&D stage (indicate application submission/approval/rejection, risks and countermeasures if rejected; future business direction and cumulative R&D expenses):
(1) Application submission/approval/rejection/results of human trials (including interim analyses)/other significant events affecting new drug R&D:
Clover's new drug CBL-514 injection for reducing abdominal subcutaneous fat has completed its IND submission to the US FDA today for the second pivotal multi-center Phase 3 clinical trial (SUPREME-02) for New Drug Application (NDA).
This trial will use MRI to measure changes in abdominal subcutaneous fat volume and the Patient Reported-Abdominal Fat Rating Scale (PR-AFRS) to assess improvement in abdominal fat grade as primary efficacy endpoints. It is expected to enroll 320 subjects in the US, Canada, and Australia. The IND application was submitted to the US FDA on April 20, 2026.
A. Clinical trial design introduction (including trial name, objective, phase, drug name, claimed indication, evaluation endpoints, planned enrollment):
a. Trial name:
A Phase 3, randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy, safety, and tolerability of CBL-514 injection in reducing abdominal subcutaneous fat (SUPREME-02).
b. Trial objective: To evaluate the efficacy, safety, and tolerability of CBL-514 injection for reducing abdominal subcutaneous fat.
c. Trial phase: Phase 3 clinical trial
d. Drug name: CBL-514
e. Claimed indication: Reduction of abdominal subcutaneous fat
f. Evaluation endpoints: Primary efficacy endpoints are changes in abdominal subcutaneous fat volume measured by MRI and assessment of abdominal fat grade improvement using PR-AFRS (Patient Report-Abdominal Fat Rating Scale).
g. Planned enrollment: Approximately 320 subjects
B. Statistical results of primary and secondary endpoints (including P-values) and statistical significance (whether statistically significant): Not applicable.
C. If statistical data for a Phase 3 human clinical trial (including interim analysis) is known, please describe the future market entry plan (note: avoid statements requiring financial forecasts for listed companies):
Not applicable.
D. Results from a single clinical trial (including statistical P-values and statistical significance of primary and secondary endpoints) are insufficient to fully reflect the success or failure of future new drug development and market entry. Investors should exercise prudent judgment and invest cautiously.
(2) Risks faced by the company and countermeasures if not approved by the competent authority, if human trial results (including interim analyses) do not achieve statistical significance, or if other significant events affect new drug R&D: Not applicable.
(3) Future business direction if approved by the competent authority, if human trial results (including interim analyses) achieve statistical significance, or if other significant events affect new drug R&D: Under evaluation by the company.
(4) Cumulative R&D expenses invested: To consider future market marketing strategies and protect the rights and interests of the company and investors, disclosure is temporarily withheld.
6. Next planned R&D stage (estimated completion time and obligations):
(1) Estimated completion time: Actual schedule will be adjusted based on clinical trial progress.
(2) Estimated obligations: None.
7. Market status:
Currently, over 80% of fat reduction treatments still use invasive surgical methods, including liposuction and abdominoplasty. Although surgical procedures have significantly more obvious fat reduction efficacy than currently marketed non-surgical fat reduction products, they still carry many apparent side effects and sequelae, and potentially life-threatening severe side effects. Therefore, non-surgical fat reduction products have rapidly emerged in recent years, including cryolipolysis, ultrasonic fat reduction, and fat-reducing injections (ingredients: deoxycholic acid or its salts), etc. However, most current non-surgical fat reduction products have poor efficacy, cannot significantly reduce subcutaneous fat in the treated area, and require more than 12 weeks to show results, accompanied by risks of moderate to severe side effects such as skin necrosis, nerve damage and paralysis, scar tissue, lumps, and paradoxical adipose hyperplasia (paradoxical ad