by Denkstrom
All storiesCBL-514 injection reduces visceral fat in study

CBL-514 injection reduces visceral fat in study

In an MRI subanalysis of two phase-2 trials of CBL-514, visceral abdominal fat volume at lumbar vertebrae L2-L3 decreased more than under placebo, according to Caliway. The data come from a small group and exist as a conference abstract. Whether this translates to weight loss or health benefits remains unclear, according to an expert.

At the annual European Association for the Study of Diabetes (EASD) conference in Milan, Caliway presented an MRI analysis of the injection CBL-514, which reduced visceral abdominal fat, the fat around internal organs, compared to placebo. According to Marie Spreckley, the visceral fat measurement involves the abdominal area at the level of the second and third lumbar vertebrae (L2-L3). According to developer Caliway Biopharmaceuticals, the average volume in the treatment group decreased by 12.01 percent four weeks after the final injection, while it increased by 5.68 percent in the placebo group.

How the injection targets fat cells

For the analysis, Garvey and Yu-Fang Ling from Caliway Biopharmaceuticals analyzed data from a participant group in phase-2 studies CBL-0204 and CBL-0205 for which MRI scans were available. Participants had a body mass index between 22 and 30 kg/m² and were between 36.4 and 42.4 years old. They received injections of up to 600 milligrams of CBL-514 or placebo into the lower abdomen every three weeks for up to twelve weeks, depending on their abdominal fat thickness. CBL-514 is intended to specifically trigger apoptosis (self-destruction of fat cells) while leaving other cells untouched, according to Caliway.

visceral fat

What the measurements show

At later follow-up, eight weeks after final treatment in CBL-0205 and twelve weeks in CBL-0204, fat volume in the CBL-514 group was 10.45 percent below baseline, while it had increased 11.76 percent in the placebo group. According to the manufacturer, baseline values were similar at 563.85 milliliters in the treatment group and 659.81 milliliters in the placebo group. According to Caliway, reactions at injection sites such as pain, swelling, and redness were mostly mild to moderate and temporary, with no serious events reported. In clinical phase-2 studies, 69.6 percent of those treated achieved at least 150 milliliters of subcutaneous fat reduction after eight weeks, compared to 0 percent under placebo, according to Caliway.

Comparison

A comparison with CBL-514 publications puts the numbers in context. Researchers published results in the journal Aesthetic Surgery Journal of a randomized, single-blind phase-2b trial with 108 adults testing CBL-514 against abdominal subcutaneous fat. There, 76.7 percent of those treated, 23 of 30, achieved improvement of at least one grade on a physician rating scale after twelve weeks, compared to 18.9 percent, 7 of 37, under placebo. The current analysis of visceral fat exists, according to Marie Spreckley, as a conference abstract without a complete peer-reviewed article.

What critics note

Justin Rochford expressed criticism to the Science Media Centre regarding the conference abstract. The study is small and the abstract names neither gender distribution nor group size. At the same time, weight gain in the placebo group amplified the apparent weight loss effect of CBL-514, though the authors disclosed this. Rochford called for studies on liver fat, blood lipids, and blood sugar control because loss of healthy body fat can be associated with metabolic problems in rare lipodystrophies. Spreckley called the findings early but encouraging evidence and named the placebo comparison and MRI measurement as strengths, but called for larger studies with longer follow-up to clarify duration and health benefits.

Caliway announced in August 2026 that the FDA cleared the application for a combined phase-2 trial of CBL-514 with Zepbound (tirzepatide) and that the pivotal phase-3 SUPREME-01 trial for large-scale abdominal fat reduction began enrolling participants after ethics committee approval. Three questions remain open: whether effects are confirmed in larger studies with longer follow-up, whether participants can maintain weight loss long-term, and whether health improvements in blood pressure, cholesterol, and blood sugar, as Garvey hopes, are sustained.