CBL-514 / Caliway Biopharmaceuticals - LARVOL DELTA

CBL-514, a first-in-class adipocyte apoptosis-inducing injection, reduces MRI-measured L2-L3 visceral adipose tissue: translational evidence from preclinical models to a Phase 2 clinical trial (EASD 2026) - "CBL-514 significantly reduced MRI-assessed L2-L3 VAT volume compared with placebo. Significant treatment differences were observed at both Week 4 and Week 8-12 for absolute and percentage changes from baseline. The findings were consistent across parametric and non-parametric analyses, supporting the efficacy of CBL-514 in reducing L2-L3 visceral adipose tissue volume in human."

Late-breaking abstract • P2 data • Preclinical • Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Caliway's CBL-514 Combination Therapy Cleared by U.S. FDA for Phase 2 Trial; Pivotal Phase 3 Trial SUPREME-01 Initiates Enrollment (PRNewswire) - "The Investigational New Drug application for CBL-0201WR, a Phase 2 clinical trial combining its first-in-class local fat-reducing new drug CBL-514 with Eli Lilly's Zepbound (Tirzepatide), has been cleared by the U.S. FDA. In addition, the pivotal Phase 3 clinical trial SUPREME-01, evaluating large-area abdominal fat reduction, has received approval from the IRB and has officially initiated enrollment."

Enrollment open • IND • Obesity

Integrating preclinical studies on CBL-514 combined GLP-1 drugs and Phase 2 clinical trial analysis "visceral fat reduction" has been selected for an oral presentation at the 62nd Annual Meeting of the European Association for the Study of Diabetes (EASD). (PRNewswire) - "The presentation will unveil to the global medical community for the first time how CBL-514 precisely reduces MRI-measured L2-L3 visceral adipose tissue volume while simultaneously reducing subcutaneous fat."

P2 data • Preclinical • Obesity

A Study to Evaluate the Maintenance of Efficacy and Long-term Safety of CBL-514 Injection for Reducing Subcutaneous Fat (Stage 1) (clinicaltrials.gov) - P3 | N=300 | Not yet recruiting | Sponsor: Caliway Biopharmaceuticals Co., Ltd.

New P3 trial

Dercum's Disease: A Practical Review of Existing and Novel Therapies. (PubMed, Plast Reconstr Surg Glob Open) - "Infliximab, which is traditionally used as an autoimmune medication targeting tumor necrosis factor alpha showed a visual reduction in lipoma size, as well as an improvement in subjective pain grading...CBL-514 is a first-in-class small-molecule inhibitor that induces apoptosis in adipose tissue...Current management of Dercum's disease revolves around medications and surgical intervention, which provide transient results and can be limited in certain populations. Novel studies are looking into off-target therapy options with the goal of presenting long-term treatment choices for clinicians to enhance management of this debilitating disease."

Journal • Review • Immunology • Oncology • Pain • Rare Diseases • TNFA

Combination of Tirzepatide with CBL-514 an Adipocyte-Apoptosis Agent Improves Weight Loss Durability and Adipose Tissue Remodeling in Diet-Induced Obese Rats (ADA 2026) - "This study evaluated whether combining tirzepatide with CBL-514 improves durability of weight loss after tirzepatide discontinuation. Diet-induced obesity rats on a high-fat diet were assigned to tirzepatide alone, CBL-514 alone, tirzepatide plus CBL-514, or a control group. Combination of tirzepatide with CBL-514 resulted in more profound weight loss, substantially enhanced subcutaneous and visceral fat reduction, and markedly attenuated post-treatment weight regain compared with tirzepatide alone, supporting adipocyte number reduction as a complementary strategy to incretin-based therapy."

Preclinical • Metabolic Disorders • Obesity

A Study to Evaluate the Efficacy, Safety, and Tolerability of CBL-514 Injection for Reducing Abdominal Subcutaneous Fat (clinicaltrials.gov) - P2 | N=250 | Recruiting | Sponsor: Caliway Biopharmaceuticals Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open

A Study to Evaluate the Efficacy, Safety, and Tolerability of CBL-514 Injection for Reducing Abdominal Subcutaneous Fat (clinicaltrials.gov) - P2 | N=250 | Not yet recruiting | Sponsor: Caliway Biopharmaceuticals Co., Ltd.

New P2 trial

A Study to Evaluate the Efficacy, Safety, and Tolerability of CBL-514 Injection for Reducing Abdominal Subcutaneous Fat (clinicaltrials.gov) - P2 | N=250 | Not yet recruiting | Sponsor: Caliway Biopharmaceuticals Co., Ltd.

New P2 trial

Caliway Announces U.S. FDA IND Clearance for CBL-0302, Its Second Global Pivotal Phase 3 Study of CBL-514 (PRNewswire) - "U.S. FDA Clearance: The Investigational New Drug (IND) application for CBL-0302 (SUPREME-02), Caliway's second multi-country pivotal Phase 3 study for its localized fat reduction candidate CBL-514, has successfully passed the FDA's 30-day review period...Caliway plans to initiate both global pivotal Phase 3 studies, CBL-0301 and CBL-0302, in the near term, anticipating clinical results in 2027...In parallel with the global pivotal Phase 3 program, Caliway continues to aggressively advance its regional clinical strategy. On May 19, the Taiwan Food and Drug Administration (TFDA) approved CBL-0206, an Asia-Pacific Phase 2 study of CBL-514. The study previously received approval from Australia's Human Research Ethics Committee (HREC)....Looking ahead, Caliway intends to submit a Phase 3 clinical study application for CBL-0304 in China during the second half of 2026."

IND • P3 data: top line • Trial status • Obesity

Randomized Phase 2b Trial of CBL-514 Injection for Abdominal Subcutaneous Fat Reduction With Clinician- and Patient-reported Outcomes and MRI Assessment. (PubMed, Aesthet Surg J) - P2 | "CBL-514 significantly reduced abdominal fat by patient- and clinician-reported outcomes and MRI, with a favorable safety profile supporting its potential as a minimally invasive option."

Journal • P2b data

CBL-514 An Adipocyte-Apoptosis Agent Enhances GLP-1 Induced Weight-loss and Attenuates Weight Regain In Diet-Induced Obese Rats (ECO 2026) - "Across two complementary GLP-1RA treatment-sequencing models, the adipocyte apoptosis inducing agent CBL-514 consistently attenuated post-treatment weight regain while improving adipose and metabolic outcomes. These findings support a durability-enhancing obesity treatment strategy in which GLP-1RA–induced weight loss is stabilized by CBL-514, thereby addressing a critical unmet need in long-term obesity management. Conflicts of Interest & Funding: All studies related to this abstract were sponsored and funded by Caliway Biopharmaceuticals."

Preclinical • Genetic Disorders • Obesity

Caliway Makes First ECO 2026 Oral Presentation on Preclinical Data of CBL-514 in Combination with GLP-1R-Based Weight-Loss Therapies, Attracting Strong Interest from International Experts and Global Pharmaceutical Companies for Its Systemic Metabolic Effects (PRNewswire) - "The study results showed that CBL-514, whether combined with semaglutide or tirzepatide, demonstrated higher weight reduction, attenuate post-discontinuation weight regain, and further reduce subcutaneous and visceral fat in animal studies. This presentation also marked the first disclosure that, following the combination of CBL-514 with GLP-1R-based weight-loss therapies, improvements in hepatic lipid content, hepatic cholesterol, and liver histopathological indicators were observed in animal studies..."

Preclinical • Obesity

A Study to Evaluate the Efficacy and Safety of CBL-514 Compared to Placebo in Participants With Dercum's Disease Lipomas (clinicaltrials.gov) - P2 | N=19 | Active, not recruiting | Sponsor: Caliway Biopharmaceuticals Co., Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Rare Diseases

A Study to Evaluate the Efficacy and Safety of CBL-514 Injection for Reducing Subcutaneous Fat ( SUPREME-02 ) (clinicaltrials.gov) - P3 | N=320 | Not yet recruiting | Sponsor: Caliway Biopharmaceuticals Co., Ltd.

New P3 trial

Caliway Selected to Present Preclinical Data on CBL-514 in Combination with GLP-1R Therapy at the American Diabetes Association's 2026 Scientific Sessions (PRNewswire) - "The title of the selected abstract is: 'Combination of Tirzepatide with CBL-514 an Adipocyte-Apoptosis Agent Improves Weight Loss Durability and Adipose Tissue Remodeling in Diet-Induced Obese Rats'."

Preclinical • Obesity

A Study to Evaluate the Efficacy and Safety of CBL-514 Injection for Reducing Subcutaneous Fat (clinicaltrials.gov) - P3 | N=300 | Not yet recruiting | Sponsor: Caliway Biopharmaceuticals Co., Ltd. | Trial completion date: Sep 2026 ➔ Jul 2027 | Initiation date: Sep 2025 ➔ Jul 2026 | Trial primary completion date: Jul 2026 ➔ May 2027

Trial completion date • Trial initiation date • Trial primary completion date

Preclinical data on Caliway's fat reduction drug candidate CBL-514 in combination with GLP-1R-based weight-loss therapies has been selected for oral presentation at the European Congress on Obesity (ECO 2026) (PRNewswire) - "The presentation will be delivered by Arya M. Sharma, MD, a globally recognized authority in obesity medicine and a scientific advisor to Caliway, who will provide scientific perspectives on the potential value of CBL-514 in expanding from aesthetic fat reduction into the obesity treatment field....The title of the presentation is: 'CBL-514 An Adipocyte-Apoptosis Agent Enhances GLP-1 Induced Weight Loss and Attenuates Weight Regain In Diet-Induced Obese Rats'."

Preclinical • Obesity

Efficacy and safety of CBL-514 for Dercum disease lipomas: A randomized phase 2a study. (PubMed, JAAD Int) - No abstract available

Journal • P2a data • Genetic Disorders • Metabolic Disorders • Pain • Rare Diseases • Rheumatology

Caliway's Fat Reduction Drug Candidate CBL-514 Completes U.S. FDA IND Submission for Phase 2 Clinical Study in Weight Management, Expanding Development Combined with GLP-1RA-Based Weight-Loss Therapies (PRNewswire) - "CBL-0201WR is a randomized, placebo-controlled Phase 2 study to be conducted at multiple centers in the United States. The study is expected to enroll approximately 120 subjects with obesity (BMI > 30) or overweight (BMI > 27) with comorbidities. The study will evaluate the efficacy, safety, and tolerability of CBL-514 in combination with Zepbound (tirzepatide, a dual GLP-1/GIP receptor agonist, Eli Lilly)."

IND • New P2 trial • Obesity

Caliway Biopharmaceuticals Presents Preclinical Research Supporting a Multi-Mechanism Approach to Weight Management at TMASO 2025 (PRNewswire) - "Under the specific conditions of the animal model, the combination group demonstrated statistically significant differences compared with incretin monotherapy across multiple parameters, including: Body-weight reduction: –21.8% (combination) vs –14.5% (monotherapy); Post-treatment weight regain: +25.2% vs +55.9% after incretin withdrawal; Subcutaneous fat reduction: –43.5% vs –15.4%; Visceral fat reduction: –41.6% vs –8.9%."

Preclinical • Obesity

"A Systematic Review of Injectable Lipolytic agents for Non-Submental Fat Reduction". (PubMed, Plast Reconstr Surg) - "Injectable lipolytic agents offer a promising, minimally invasive alternative for fat reduction in non-submental regions. However, further clinical trials are needed to standardize treatment protocols, evaluate long-term efficacy, and assess the cost-effectiveness of combining injectables with other weight management strategies. Expanding FDA approval for additional indications remains a potential future direction."

Journal • Aesthetic Medicine • Obesity

Caliway Met Dual Milestones... (PRNewswire) - "Caliway (6919) has been added to the Taiwan component of the MSCI Global Standard Index, effective after market close on August 26, 2025, marking recognition from the international capital market. CBL-514's global pivotal Phase 3 study SUPREME-01, following U.S. FDA clearance, has now also received approval from Health Canada. The study is expected to begin recruitment in Q3 2025 across the U.S. and Canada, targeting 300 participants."

Commercial • New P3 trial • Obesity

A Phase 3 Study to Evaluate the Efficacy and Safety of CBL-514 Injection for Reducing Subcutaneous Fat (clinicaltrials.gov) - P3 | N=300 | Not yet recruiting | Sponsor: Caliway Biopharmaceuticals Co., Ltd.

New P3 trial

A Study to Evaluate the Efficacy and Safety of CBL-514 Compared to Placebo in Participants With Dercum's Disease Lipomas (clinicaltrials.gov) - P2 | N=20 | Recruiting | Sponsor: Caliway Biopharmaceuticals Co., Ltd. | N=30 ➔ 20

Enrollment change • Rare Diseases