Consistent administration of Gelesis100, a nonsystemic, superabsorbent hydrogel in oral capsule form, can double the odds for meaningful weight loss in adults with overweight or obesity compared with lifestyle modifications alone, according to findings published in Obesity.
“There is ... an urgent need for therapies that increase patients’ odds for achieving clinically meaningful weight loss with little or no additional safety risk compared with lifestyle interventions,” Frank Greenway, MD, professor and chief medical officer of the Pennington Biomedical Research Center in Baton Rouge, Louisiana, and colleagues wrote. “Such therapies could allow clinicians to intervene earlier in the overweight and obesity continuum and prevent progression or delay associated comorbidities while helping to overcoming the current therapeutic inertia.”
To evaluate the efficacy and safety of Gelesis100 (Gelesis), Greenway and colleagues conducted a 24-week multicenter, randomized, double-blind, placebo-controlled trial with 436 adults aged 22 to 65 years and with a BMI between 27 kg/m2 and 40 kg/m2.
Participants were divided into two groups, with one group receiving Gelesis100 (n = 223; mean age, 48.2 years; 56.1% women; mean BMI, 33.5 kg/m2) and the other receiving placebo (n = 213; mean age, 47.8 years; 56.3% women; mean BMI, 34.1 kg/m2). Participants took three capsules of Gelesis100 (2.25 g) or three placebo capsules with water before lunch and dinner each day for the 24 weeks of the trial. Participants were encouraged to exercise moderately each day and to decrease their diet by 300 kcal per day.
The Gelesis100 group lost an average of 6.4% of body weight compared with a loss of 4.4% by those in the placebo group, which demonstrated superiority of the treatment but not the required 3% difference for super superiority, according to the researchers.
More than half of the Gelesis100 cohort lost at least 5% of baseline body weight (59%) compared with 42% of those in the placebo group. In addition, weight loss of 10% or more was achieved by 27% of the Gelesis100 group compared with 15% of the placebo group. Participants in the Gelesis100 cohort group were twice as likely to reach weight loss of 5% (OR = 2; P = .0008), 7.5% (OR = 2.1; P = .0017) and 10% (OR = 2.1; P = .0107) compared with placebo.
Among participants with prediabetes (fasting plasma glucose 100 mg/dL) or drug-naive type 2 diabetes (FPG 126 mg/dL) who took Gelesis100, 53% lost at least 7.5% of baseline body weight and 44% surpassed 10%. One-quarter of similar participants in the placebo group achieved 7.5% weight loss and 14% reached 10% weight loss. Ultimately, participants with prediabetes or drug-naive type 2 diabetes were 6.1 times more likely to reach 10% weight loss than their placebo group counterparts.
Most adverse events during the trial were gastrointestinal, with 158 gastrointestinal adverse events reported by participants in the Gelesis100 group compared with 58 events in the placebo group (P = .0248). The researchers noted that most events were mild and that there was little difference in total number of adverse events between the two groups.
After the initial trial, the researchers conducted a 48-week extension with 39 participants, including 21 from the Gelesis100 group and 18 from the placebo group. For the participants who continued the Gelesis100 treatment, the mean weight loss before the extension was 7.1% and the mean weight loss at 48 weeks was 7.6% (P < .0001). For participants in the placebo group during the initial trial, a mean weight loss of 7.1% was recorded before the extension and a mean weight loss of 9.4% was achieved at 48 weeks (P < .0001).
“New tools are needed to supplement lifestyle management for treatment of overweight and obesity. There is a particular need for treatments that produce significant weight loss without major [adverse events],” the researchers wrote. “The outstanding safety profile of Gelesis100 combined with its demonstrated efficacy should make it an attractive option for obesity treatment.” – by Phil Neuffer
Disclosures: This study was funded by Gelesis Inc. Greenway reports he has received funding/grant support/honorarium from A2 Milk, Baronova, Basic Research, General Nutrition Corp., JennyCraig/Curves, Microbiome Therapeutics, NeuroQuest, Novartis, Novo Nordisk, NuSirt, Plensat, Zafgen and Zaluvida. Please see the full study for all other authors’ relevant financial disclosures.