2026. 10
Date： 2026.10.02 -
EASD Press Room Features New Data on CBL-514 for Reducing Subcutaneous and Visceral Fat
The following article was published by the EASD Press Room and highlights research findings on CBL-514 presented at the EASD Annual Meeting 2026 in Milan, Italy.
New weight-loss injection targets fat cells
Studies show that the new drug, CBL-514, reduces levels of subcutaneous and visceral fat. The data also suggest that it helps attenuate weight regain on stopping GLP-1 receptor agonist drugs (GLP1-RAs), says Dr W. Timothy Garvey, of the University of Alabama at Birmingham, Birmingham, USA.
CBL-514 selectively induces apoptosis (self-destruction) of adipocytes, or fat cells, while leaving other cells untouched.
In phase 2 clinical trials, the drug reduced the volume of subcutaneous adipose tissue – the layer of fat that lies just beneath the skin and can be “pinched” – with 69.6% of treated participants achieving a reduction of at least 150 mL at the 8-week follow-up, compared with 0% of those receiving placebo1.
In preclinical studies2 (animal models), it reduced weight and levels of subcutaneous and visceral abdominal tissue (VAT). Visceral fat is hidden deep within the abdomen, wrapped around the internal organs. It is very metabolically active and a key driver of insulin resistance, type 2 diabetes and cardiometabolic conditions such as heart attacks and strokes.
More weight was lost when the drug was given along with the GLP1-RA tirzepatide. In addition, rats given CBL-514 and tirzepatide regained less weight when tirzepatide was stopped than rats given tirzepatide alone.
The hypothesis is that the reduction in fat cells limits the amount of fat that can be reaccumulated, slowing weight regain.
While GLP1-RAs are highly effective for weight loss, many people regain weight after stopping treatment. The hope is that CBL-514 will help people keep weight off – allowing them to sustain the health benefits of weight loss, such as improvements in blood pressure, blood sugar and cholesterol, says Professor Garvey. However, research is needed to prove this.
For the latest analysis, Prof Garvey and Ms Yu-Fang Ling, of the drug’s developer, Caliway Biopharmaceuticals, in New Taipei City, Taiwan used data on a subgroup of participants from the phase 2 trials (CBL-0204 and CBL-0205) to assess CBL-514’s effect on visceral fat in human subjects. They focused on trial participants for whom MRI data was available.
The participants (BMI 22-30 kg/m2) received a course of injections, with the exact number depending on the thickness of their abdominal fat, of up to 600mg of CBL-514 (n=23) or placebo (n=17) (age range 36.4 years to 42.4 years) into the lower abdomen every three weeks for up to 12 weeks The number of injections was reduced as the participant’s fat thickness decreased and were stopped when the thickness reached a low enough level. MRI scans were used to measure visceral adipose tissue at baseline, four and eight to 12 weeks after the last treatment.
The baseline sex distribution for the VAT subgroup was as follows:
(Note: The baseline VAT subgroup included 41 participants (CBL-514, n=23; placebo, n=18). The 40 participants reported in the press release (CBL-514, n=23; placebo, n=17) refer to those with available 8–12-week follow-up data)
VAT volume was similar in the two groups at baseline: 563.85 ml in the CBL-514 group and 659.81 ml in the placebo group. It then decreased in those receiving the drug and increased in those given the placebo.
Four weeks after the last treatment, average VAT volume had decreased by 12.01% from baseline in the CBL-514 group, while it had increased by 5.68% in the placebo group, representing a between-group difference of 17.69%
At the later follow-up – 8 weeks after the last treatment in CBL-0205 and 12 weeks after the last treatment in CBL-0204 – average VAT volume was 10.45% lower than at baseline in the CBL-514 group, while it had increased by 11.76% in the placebo group, representing a between-group difference of 22.21%.
Other than mostly mild-to-moderate and transient injection-site reactions, such as pain, swelling and redness, CBL-514 was generally well tolerated, with no serious adverse events reported.
The researchers conclude that CBL-514 significantly reduced abdominal VAT volume compared with placebo – and that the research as a whole shows that the drug can reduce both visceral and subcutaneous fat.
Professor Garvey says: “We expect that patients will be pleased by the cosmetic effects, such as the flatter stomach that can come with subcutaneous fat loss. But it is the reduction in body weight, loss of visceral fat and the improvements in blood pressure, cholesterol and the like that should be associated with this that will be important for health.”
He adds that liposuction and abdominoplasty only address subcutaneous fat and are more invasive.
“This is a highly innovative approach to obesity pharmacotherapy that has produced some remarkable results in early human trials,” says Professor Garvey.
Recruitment for the first of two phase 3 trials is under way. These randomized placebo-controlled studies will evaluate the safety and efficacy of CBL-514 for nonsurgical abdominal fat reduction, with the first results expected at the end of next year.
Source: European Association for the Study of Diabetes (EASD) Press Room
Original Article Title: "New weight-loss injection targets fat cells"
*About CBL-514
CBL-514 is a patented, first-in-class small-molecule 505(b)(1) injection developed by Caliway. It is designed to selectively induce adipocyte apoptosis to precisely reduce subcutaneous fat at the injection site without causing necrosis or damage to surrounding tissues or cells.
CBL-514 has demonstrated broad therapeutic potential across multiple indications, including non-surgical subcutaneous fat reduction and moderate-to-severe cellulite. A separate formulation, designated as CBL-514D, is being developed for the treatment of Dercum’s Disease, a rare disease. To date, more than 544 subjects have participated in clinical trials related to CBL-514. Across the 10 completed clinical trials with finalized statistical reports, all primary and key secondary efficacy endpoints have been met, demonstrating excellent safety and tolerability.
*About Caliway Biopharmaceuticals
Caliway Biopharmaceuticals Co., Ltd. (TWSE: 6919), founded in 2012, is dedicated to developing breakthrough therapeutics that redefine standards of care and transform clinical practices. Caliway aims to leverage Taiwan's robust pharmaceutical research and development capabilities to serve the global aesthetic medicine and biomedical markets. The company was officially listed on the Taiwan Stock Exchange (TWSE: 6919) on October 2, 2024.
*Disclaimer
This press release and related web pages contain forward-looking statements that are based on the Company's current expectations, forecasts, and assessments. These statements involve risks, uncertainties, and other factors beyond the Company’s control. Actual events or results may differ materially from those projected in these forward-looking statements due to various external factors. Caliway undertakes no obligation to update or revise any information in this press release.
*Media & Investor Relations Contact
ir@caliwaybiopharma.com
New weight-loss injection targets fat cells
- CBL-514 is designed to reduce levels of subcutaneous and visceral fat
- Phase 3 trial recruitment has started
Studies show that the new drug, CBL-514, reduces levels of subcutaneous and visceral fat. The data also suggest that it helps attenuate weight regain on stopping GLP-1 receptor agonist drugs (GLP1-RAs), says Dr W. Timothy Garvey, of the University of Alabama at Birmingham, Birmingham, USA.
CBL-514 selectively induces apoptosis (self-destruction) of adipocytes, or fat cells, while leaving other cells untouched.
In phase 2 clinical trials, the drug reduced the volume of subcutaneous adipose tissue – the layer of fat that lies just beneath the skin and can be “pinched” – with 69.6% of treated participants achieving a reduction of at least 150 mL at the 8-week follow-up, compared with 0% of those receiving placebo1.
In preclinical studies2 (animal models), it reduced weight and levels of subcutaneous and visceral abdominal tissue (VAT). Visceral fat is hidden deep within the abdomen, wrapped around the internal organs. It is very metabolically active and a key driver of insulin resistance, type 2 diabetes and cardiometabolic conditions such as heart attacks and strokes.
More weight was lost when the drug was given along with the GLP1-RA tirzepatide. In addition, rats given CBL-514 and tirzepatide regained less weight when tirzepatide was stopped than rats given tirzepatide alone.
The hypothesis is that the reduction in fat cells limits the amount of fat that can be reaccumulated, slowing weight regain.
While GLP1-RAs are highly effective for weight loss, many people regain weight after stopping treatment. The hope is that CBL-514 will help people keep weight off – allowing them to sustain the health benefits of weight loss, such as improvements in blood pressure, blood sugar and cholesterol, says Professor Garvey. However, research is needed to prove this.
For the latest analysis, Prof Garvey and Ms Yu-Fang Ling, of the drug’s developer, Caliway Biopharmaceuticals, in New Taipei City, Taiwan used data on a subgroup of participants from the phase 2 trials (CBL-0204 and CBL-0205) to assess CBL-514’s effect on visceral fat in human subjects. They focused on trial participants for whom MRI data was available.
The participants (BMI 22-30 kg/m2) received a course of injections, with the exact number depending on the thickness of their abdominal fat, of up to 600mg of CBL-514 (n=23) or placebo (n=17) (age range 36.4 years to 42.4 years) into the lower abdomen every three weeks for up to 12 weeks The number of injections was reduced as the participant’s fat thickness decreased and were stopped when the thickness reached a low enough level. MRI scans were used to measure visceral adipose tissue at baseline, four and eight to 12 weeks after the last treatment.
The baseline sex distribution for the VAT subgroup was as follows:
(Note: The baseline VAT subgroup included 41 participants (CBL-514, n=23; placebo, n=18). The 40 participants reported in the press release (CBL-514, n=23; placebo, n=17) refer to those with available 8–12-week follow-up data)
VAT volume was similar in the two groups at baseline: 563.85 ml in the CBL-514 group and 659.81 ml in the placebo group. It then decreased in those receiving the drug and increased in those given the placebo.
Four weeks after the last treatment, average VAT volume had decreased by 12.01% from baseline in the CBL-514 group, while it had increased by 5.68% in the placebo group, representing a between-group difference of 17.69%
At the later follow-up – 8 weeks after the last treatment in CBL-0205 and 12 weeks after the last treatment in CBL-0204 – average VAT volume was 10.45% lower than at baseline in the CBL-514 group, while it had increased by 11.76% in the placebo group, representing a between-group difference of 22.21%.
Other than mostly mild-to-moderate and transient injection-site reactions, such as pain, swelling and redness, CBL-514 was generally well tolerated, with no serious adverse events reported.
The researchers conclude that CBL-514 significantly reduced abdominal VAT volume compared with placebo – and that the research as a whole shows that the drug can reduce both visceral and subcutaneous fat.
Professor Garvey says: “We expect that patients will be pleased by the cosmetic effects, such as the flatter stomach that can come with subcutaneous fat loss. But it is the reduction in body weight, loss of visceral fat and the improvements in blood pressure, cholesterol and the like that should be associated with this that will be important for health.”
He adds that liposuction and abdominoplasty only address subcutaneous fat and are more invasive.
“This is a highly innovative approach to obesity pharmacotherapy that has produced some remarkable results in early human trials,” says Professor Garvey.
Recruitment for the first of two phase 3 trials is under way. These randomized placebo-controlled studies will evaluate the safety and efficacy of CBL-514 for nonsurgical abdominal fat reduction, with the first results expected at the end of next year.
Source: European Association for the Study of Diabetes (EASD) Press Room
Original Article Title: "New weight-loss injection targets fat cells"
*About CBL-514
CBL-514 is a patented, first-in-class small-molecule 505(b)(1) injection developed by Caliway. It is designed to selectively induce adipocyte apoptosis to precisely reduce subcutaneous fat at the injection site without causing necrosis or damage to surrounding tissues or cells.
CBL-514 has demonstrated broad therapeutic potential across multiple indications, including non-surgical subcutaneous fat reduction and moderate-to-severe cellulite. A separate formulation, designated as CBL-514D, is being developed for the treatment of Dercum’s Disease, a rare disease. To date, more than 544 subjects have participated in clinical trials related to CBL-514. Across the 10 completed clinical trials with finalized statistical reports, all primary and key secondary efficacy endpoints have been met, demonstrating excellent safety and tolerability.
*About Caliway Biopharmaceuticals
Caliway Biopharmaceuticals Co., Ltd. (TWSE: 6919), founded in 2012, is dedicated to developing breakthrough therapeutics that redefine standards of care and transform clinical practices. Caliway aims to leverage Taiwan's robust pharmaceutical research and development capabilities to serve the global aesthetic medicine and biomedical markets. The company was officially listed on the Taiwan Stock Exchange (TWSE: 6919) on October 2, 2024.
*Disclaimer
This press release and related web pages contain forward-looking statements that are based on the Company's current expectations, forecasts, and assessments. These statements involve risks, uncertainties, and other factors beyond the Company’s control. Actual events or results may differ materially from those projected in these forward-looking statements due to various external factors. Caliway undertakes no obligation to update or revise any information in this press release.
*Media & Investor Relations Contact
ir@caliwaybiopharma.com