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A key limitation of endoscopic sleeve gastroplasty (ESG) might be overcome by adding a diabetes drug to follow-up care, a small sham-controlled trial from Brazil suggested.

Patients who took semaglutide (Ozempic) following ESG showed significantly greater losses of body fat and lower HbA1c levels compared with those who had only usual care after the procedures, said Anna Carolina Hoff, MD, of Angioskope Brazil in São José dos Campos, during a press briefing held in advance of the annual meeting.

With 58 patients evaluable, body fat mass losses at the 1-year follow-up after ESG averaged 9.0 percentage points in the usual care group versus 12.7 with add-on semaglutide (P<0.001), Hoff said. Mean HbA1c levels at that point were 5.33% with usual care versus 4.38% in the semaglutide group (P<0.006).

Baseline values for these parameters were:

• Body fat mass percentage: 44.61% usual care, 42.61% semaglutide

• HbA1c: 5.86% in both usual care and semaglutide groups

Patients were randomized to the two study arms. Those in the usual care group were given injector pens similar to those used for semaglutide but loaded with saline.

Semaglutide was given weekly beginning 5 months after ESG, with 0.25 mg as the starting dose and titrated upward to a maximum of 1.5 mg. Doses were adjusted weekly on the basis of symptoms. ESG was performed in the same way for both treatment groups, and instructions for post-procedure diet and exercise were also the same.

Dose-related nausea and other gastrointestinal symptoms were the most common adverse effects seen with semaglutide; the drug's safety profile was in line with previous studies.

The biggest drop in mean HbA1c levels in the semaglutide group occurred between months 9 and 12 of follow-up -- from 5.18% to 4.38% -- suggesting that further decreases over time could be anticipated.

As might be expected with semaglutide -- shown in recent studies to be an effective weight-loss drug on its own -- loss of body weight was greater in the patient receiving the agent (26.7% vs 19.6%, P<0.001). Similarly, loss of "excess" weight averaged 86.3% with semaglutide versus 60.4% with usual care.

But Hoff wanted to emphasize the metabolic effects of add-on semaglutide beyond weight loss. She explained that ESG has been proven to induce substantial weight loss, though less than with more invasive alternatives such as laparoscopic sleeve gastrectomy or Roux-en-Y bypass surgery, which also can be a in obese patients.

"Procedural modifications [to ESG] have not reproduced the significant degree of hormone alterations demonstrated in bariatric surgery," Hoff said.

At the same time, not all patients are eligible for the more invasive surgeries or would simply prefer the endoscopic approach. "Fewer than 2% of eligible patients pursue" bariatric surgery, she said, noting that ESG can be appropriate for patients who are less obese than the standard cutoffs for laparoscopic or open procedures. ESG is performed by inserting an endoscope through the patient's throat and suturing the stomach to reduce its capacity.

Hoff concluded that the results of this pilot study were "particularly exciting because ESG can be performed at an earlier stage of the disease [than conventional bariatric surgery] and at a lower [body mass index], meaning more patients can get to the treatment before the disease is progressing."

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