Lara C. Pullen, PhD

June 26, 2014

CHICAGO — Overweight and obese patients who took 2 doses a day of a novel, biocompatible hydrogel that is not systemically absorbed were able to significantly decrease their body weight, according to a new proof-of-concept study.

The product, Gelesis100 (Gelesis), contains thousands of tiny hydrogel particles, administered in capsules that dissolve and expand in the stomach and mix with ingested food, creating a larger volume and inducing satiety, but then later eliminated.

The capsules are taken prior to a meal, and after swallowing them, the patient drinks water, which the particles inside the capsule then absorb, leading to the expansion in volume, which is capped by the amount of liquid in the stomach or the small intestine.

The new study included 2 doses of Gelesis100 and a placebo. "The low dose is really the best dose in terms of efficacy and safety," explained Hassan Meshmati, MD, chief medical officer for Gelesis and a study coinvestigator, who presented the findings in a poster and during a press conference at ICE/ENDO 2014 earlier this week.

Daniel H. Bessesen, MD, professor of medicine at the University of Colorado in Denver, spoke with Medscape Medical News about Gelesis100. He said it appears to represent an effective and safe approach to weight loss, although he pointed out that the effect was not dramatic.

"It's not trivial, but it's also not a huge amount of weight loss," he explained. He also expressed interest in seeing long-term data: "Is there continued weight loss or not? We don't know unless we test it." He added that most weight-loss approaches require lifetime adherence.

Higher Dose Associated With Poor Tolerability and Adherence

The randomized double-blind study included 128 nondiabetic overweight (body mass index [BMI] >25 and <30) and obese (BMI >30) patients at 5 sites in 3 countries (Denmark, Italy, and the Czech Republic).

Patients were randomized to receive 2.25 g of Gelesis100 twice a day with water, before a meal (n=43), 3.75 g of Gelesis100 under the same conditions (n=42), or a placebo capsule containing cellulose (n=43). All subjects were instructed to eat 600 calories less per day.

After 12 weeks of treatment, the low-dose group lost approximately 6% of their body weight, and the subjects didn't experience a weight-loss plateau during the 12 weeks of treatment.

Those on the higher dose lost only 4.5% of body weight, compared with 4.1% for placebo. Dr. Meshmati hypothesized that the higher-dose group lost less weight because of tolerability issues, leading to lower compliance; this dose appeared to precipitate flatulence, abdominal pain, and diarrhea. These side effects occurred less often with the lower dose and were more tolerable at that dose, he observed.

Individuals with prediabetes (fasting glucose >100 mg/dL and <126 mg/dL) had the most dramatic weight loss (average 10.9% of body weight), leading the investigators to speculate that Gelesis100 might reduce the absorption of glucose.

Body Weight Response in the Intention-to-Treat Population

Parameter Genesis100 2.25 g, n=42 Genesis100 3.75 g, n=41 Placebo, n =42
  n % n % n %
Weight gain 3 7 9 22 7 17
Weight loss <5% 21 50 13 32 18 43
Weight loss >5% 18 43 19 46 17 40
Weight loss >10% 11 26 5 12 5 12

Also asked to comment, Caroline M. Apovian, MD, chair of the Endocrine Society task force on pharmacologic management of the obese patient, told Medscape Medical News that Genesis100 appears to be safe, so "it will be another good tool to use."

Gelesis is a clinical-stage company developing a new category of therapy to safely treat overweight, obese, and diabetic subjects. Dr. Apovian and Dr. Bessesen report no relevant financial relationships.

Joint Meeting of the International Society of Endocrinology and the Endocrine Society: ICE/ENDO 2014; June 23, 2014. Abstract SUN-0897



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