For weight management in adults with a body mass index (BMI) of 25 – 40 kg/m2, when used together with diet and exercise.

Gelesis trade name.

It is a capsule containing hydrogel particles that expand in the stomach after they are ingested but are not systemically absorbed, making the user feel full.

They are taken twice daily with water before meals.

Multicenter, double-blind, placebo-controlled pivotal trial that assessed body weight change in 436 adult patients with overweight or obesity (BMI ≥ 27 and ≤ 40 kg/m2) after completing 6 months of treatment.

59% of those in the treatment group experiencing at least a 5% weight loss.

Those who received Gelesis100 were twice as likely to achieve at least 5% weight loss when compared with placebo.

More than a quarter experienced at least a 10% weight loss.

Participants in this group lost an average of 15% or approximately 30 pounds of weight loss.

Adverse events were similar in the treatment and placebo groups.

The most frequently seen adverse events were gastrointestinal disorders (38% in the Gelesis100 group vs 28% in the placebo group), infections and infestations (1% in each of the Gelesis100 and placebo groups), and musculoskeletal and connective tissue disorders (1% in the Gelesis100 group and 0% in the placebo group).

No serious adverse events occurred in the Gelesis100 group.

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