Caliway Presents New Data on CBL-514 Combination Therapy at ADA 2026

Caliway Biopharmaceuticals has announced new preclinical data for its investigational drug candidate, CBL-514, at the American Diabetes Association (ADA) 2026 Scientific Sessions. The latest research focused on combining CBL-514 with GLP-1 receptor-based weight-loss therapies, particularly tirzepatide, one of the leading treatments currently used for obesity and weight management.

The findings attracted significant attention from obesity specialists, metabolic disease experts, and representatives from global pharmaceutical companies attending the conference.

What Is CBL-514?

CBL-514 is a first-in-class injectable drug being developed by Caliway for localized fat reduction. Unlike traditional fat-reduction approaches, the drug is designed to selectively trigger the natural death of fat cells in the treatment area without damaging surrounding tissues.

The company is also exploring its potential role in weight management and metabolic health through combination therapies.

ADA 2026 Presentation Highlights

The latest data were presented by Dr. Timothy Garvey, a globally recognized expert in obesity and metabolic medicine and a scientific advisor to Caliway.

The presentation focused on results from the OI25 animal study, which evaluated the effects of combining CBL-514 with tirzepatide.

According to the data, the combination therapy delivered stronger results than tirzepatide alone in several important areas, including weight loss, weight maintenance, liver fat reduction, and insulin resistance.

Addressing a Major Challenge: Weight Regain After Treatment

One of the biggest concerns with current weight-loss medications is that many patients regain weight after stopping treatment.

The OI25 study specifically examined whether CBL-514 could help reduce this rebound effect.

Researchers found that animals treated with tirzepatide alone regained 46.1% of their lost weight after treatment ended. In comparison, those receiving the CBL-514 and tirzepatide combination regained only 17.1%.

This means weight regain in the tirzepatide-only group was approximately 2.7 times higher than in the combination therapy group.

These findings suggest that adding CBL-514 may help maintain weight-loss results for a longer period after treatment is discontinued.

Additional Benefits Beyond Weight Loss

The study also revealed promising improvements in metabolic health.

Significant Reduction in Liver Fat

Researchers observed a substantial decrease in hepatic lipid content, commonly known as liver fat.

The combination therapy produced an additional 106.7% reduction in liver fat compared to tirzepatide alone.

This finding is important because excess liver fat is closely linked to metabolic disorders and can contribute to serious health complications over time.

Improvement in Insulin Resistance

The study also showed meaningful improvements in insulin resistance, measured using the HOMA-IR index.

Both treatment groups showed benefits, but the combination therapy demonstrated particularly encouraging results.

Improving insulin sensitivity can help support better metabolic health and may reduce the risk of conditions associated with obesity.

Growing Scientific Interest in Combination Therapies

According to Caliway, the presentation generated strong interest from healthcare professionals and pharmaceutical companies attending ADA 2026.

Laura Chung, Vice President of Caliway, noted that many clinical investigators approached the company to learn more about the latest findings and upcoming development plans.

She also stated that there is growing patient interest in future clinical studies involving CBL-514.

Previous Research Supports the Latest Findings

The OI25 study builds upon earlier animal studies conducted by Caliway.

Previous studies, including OI21 and OI23, evaluated CBL-514 in combination with leading GLP-1 receptor-based therapies such as semaglutide and tirzepatide.

Those studies consistently demonstrated several potential benefits, including:

• Enhanced weight loss
• Reduced weight regain after treatment discontinuation
• Significant reduction in both subcutaneous and visceral fat
• Improvements in metabolic health markers

The newly presented OI25 data further strengthen the scientific evidence supporting this combination approach.

Human Clinical Trials Planned for 2026

Following the encouraging preclinical results, Caliway plans to advance the program into human clinical trials during the second half of 2026.

The company also intends to continue expanding its global clinical development efforts and pursue international licensing opportunities for CBL-514.

The goal is to further explore how the drug can complement existing obesity treatments and potentially improve long-term outcomes for patients.

Why These Findings Matter

Obesity remains one of the world's fastest-growing health challenges. While GLP-1 therapies have transformed weight management in recent years, maintaining weight loss after treatment remains a major hurdle.

The latest data suggest that CBL-514 may help address this challenge by enhancing weight-loss outcomes and reducing the likelihood of weight regain after therapy ends.

In addition, the observed improvements in liver fat and insulin resistance indicate that the drug could potentially offer benefits beyond localized fat reduction.

Although these findings are currently limited to preclinical studies, they provide an important foundation for future human research.

Looking Ahead

CBL-514 continues to emerge as a promising candidate in the obesity and metabolic health space. With positive results across multiple preclinical studies and plans for human trials later this year, the drug is attracting increasing attention from researchers and industry experts.

As Caliway advances development, upcoming clinical studies will help determine whether the encouraging benefits seen in animal models can translate into meaningful outcomes for people living with obesity and related metabolic conditions.

About Caliway Biopharmaceuticals

Founded in 2012, Caliway Biopharmaceuticals is focused on developing innovative therapies that address unmet medical needs in both aesthetic medicine and broader healthcare markets.

The company specializes in creating novel treatment options designed to improve patient outcomes while advancing scientific innovation. Caliway was officially listed on the Taiwan Stock Exchange in October 2024 and continues to expand its global development programs across multiple therapeutic areas.