American Association of Clinical Endocrinology Annual Meeting

American Association of Clinical Endocrinology Annual Meeting

Source:

Still C, et al. Plenity treatment in the Gelesis Loss of Weight (GLOW) study is associated with improvement in liver health, as measured by NAFLD fibrosis score. Presented at: American Association of Clinical Endocrinology Annual Scientific and Clinical Conference; May 26-29, 2021 (virtual meeting).

Disclosures: Still reports he has received consultant and speaker fees from Covidien, Ethicon Endo-Surgery and Novo Nordisk, and has received research grants from Ethicon Endo-Surgery.
June 11, 2021
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Hydrogel capsule for weight loss may reduce risk for liver fibrosis

Source:

Still C, et al. Plenity treatment in the Gelesis Loss of Weight (GLOW) study is associated with improvement in liver health, as measured by NAFLD fibrosis score. Presented at: American Association of Clinical Endocrinology Annual Scientific and Clinical Conference; May 26-29, 2021 (virtual meeting).

Disclosures: Still reports he has received consultant and speaker fees from Covidien, Ethicon Endo-Surgery and Novo Nordisk, and has received research grants from Ethicon Endo-Surgery.
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An oral hydrogel capsule for treatment of obesity may reduce liver fibrosis risk, according to an exploratory analysis of the GLOW study presented at the American Association of Clinical Endocrinology annual meeting.

“We know that patients with excess weight are at increased risk for developing nonalcoholic fatty liver disease, or NAFLD,” Christopher Still, DO, FACP, medical director for the Center for Nutrition and Weight Management and director of the Geisinger Obesity Research Institute at Geisinger Medical Center, told Healio. “This chronic disease is a silent disease because its early development is generally asymptomatic but can progress to nonalcoholic steatohepatitis, liver fibrosis, cirrhosis and liver cancer. The first-line treatment for NAFLD is weight loss, and we know that around 7% weight loss can result in improved liver enzymes and less liver inflammation. Since we collected all of the clinical values that are used to calculate the NAFLD fibrosis score as part of GLOW, it was a natural question to ask whether [hydrogel therapy] could impact participants’ NAFLD fibrosis score.”

Still is the medical director for the Center for Nutrition and Weight Management and director of the Geisinger Obesity Research Institute at Geisinger Medical Center.

Novel obesity treatment

As Healio previously reported, 2019 data from the GLOW study showed that consistent administration of Gelesis100 (Plenity), 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. 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. The capsule induces feelings of fullness without adding calories for adults with overweight and obesity. The FDA cleared oral hydrogel therapy for obesity in April 2019.

Examining NAFLD risk

For the exploratory analysis, Still and colleagues examined the impact of hydrogel therapy on liver health among 317 GLOW participants, as measured by the NAFLD fibrosis score, which predicts the presence of significant fibrosis using common clinical and laboratory values. NAFLD fibrosis score was categorized as higher (combining intermediate and high; score –1.45) or lower (score < –1.45) probability of liver fibrosis. The absolute and categorical scores were calculated at baseline and 6 months for the entire cohort, those with prediabetes or type 2 diabetes at baseline, and participants who lost at least 10% of body weight.

At baseline, 53.6% of participants in the oral hydrogel group and 53.7% in the placebo group had a NAFLD fibrosis score in the higher probability for fibrosis category (P = .98).

“Most participants in GLOW did not have moderate or even severe obesity, so I was surprised that about 50% of participants in both groups had an intermediate or high likelihood of liver fibrosis [at baseline],” Still told Healio. “In addition, when we restricted the analyses to participants with prediabetes or type 2 diabetes, this number increased to about 80% for the Plenity and placebo patients. It is further confirming how fatty liver disease is becoming the next epidemic, going hand in hand with obesity and diabetes epidemics.”

At the end of treatment, more participants in the hydrogel group were in the lower probability risk category for NAFLD fibrosis score (P = .016). There was no difference observed for the placebo group. In the overall cohort, there was a statistically significant reduction in the absolute mean change in NAFLD fibrosis score for the hydrogel group (mean, –0.15; P = .03), but not in the placebo group (mean, 0.02; P = .824). The difference between groups was significant (P = .043).

In subgroup analyses, those with type 2 diabetes in both the hydrogel and placebo groups saw a reduction in NAFLD fibrosis score, with mean reductions of –0.53 (P < .0001) and –0.34 (P = .0097), respectively.

Similarly, more participants in the hydrogel group were in the lower-risk NAFLD fibrosis score category at end of treatment (P = .004) but not placebo (P = .135).

Among participants who lost as least 10% of body weight (44 in hydrogel group; 25 in placebo), the absolute mean change in NAFLD fibrosis score was greater for those in the hydrogel group (–0.37 vs. –0.34), and more participants in the hydrogel group were in the lower-risk NAFLD fibrosis score category at end of treatment (P = .0143).

Still said that clinical trials are underway to examine the long-term impact of hydrogel pill therapy on the development and treatment of fatty liver disease.

“These results reinforce that intervening early matters,” Still told Healio.