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A First-in-Human Study of GLY-200, an Oral, Gut- Restricted, Pharmacologic Duodenal Exclusion Therapy

Obesity (Silver Spring, Md.), 2022-11, Vol.30, p.19-19 [Peer Reviewed Journal]

Copyright Blackwell Publishing Ltd. Nov 2022 ;ISSN: 1930-7381 ;EISSN: 1930-739X

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  • Title:
    A First-in-Human Study of GLY-200, an Oral, Gut- Restricted, Pharmacologic Duodenal Exclusion Therapy
  • Author: Fineman, Mark ; Bryant, Christine ; Colbert, Kevin ; Jozefiak, Thomas ; Petersen, John ; Vora, Jiten ; Rayner, Christopher ; Wabnitz, Paul ; Nimgaonkar, Ashish
  • Subjects: Glucose
  • Is Part Of: Obesity (Silver Spring, Md.), 2022-11, Vol.30, p.19-19
  • Description: Background: Roux-en-Y gastric bypass (RYGB) surgery is a successful long-term therapy for obesity and T2DM inducing an immediate, significant improvement in glucose homeostasis, at least in part through duodenal exclusion. GLY-200 is an oral, pH activated, GI lumenrestricted, non-absorbed polymer that interacts with proximal small intestinal mucus to create a temporary barrier replicating duodenal exclusion physiology, producing improvements in weight and glycemic control in several models of T2DM. Methods: A Phase 1, randomized, double-blind, placebo (PBO)-controlled, single and multiple ascending dose (SAD and MAD) study was conducted in healthy volunteers. SAD study: 4 cohorts received a single oral dose of 0.5 g to 6.0 g GLY-200 or PBO. MAD study: 4 cohorts received 5 days of BID or TID oral dosing (total daily dose 2.0 g to 6.0 g GLY-200 or PBO). Assessments included safety and tolerability (primary) and exploratory pharmacodynamics (e.g., daily weight, serum bile acids, and glucose). Results: No safety signals were observed in SAD (N=32, 18-63 y, BMI 25.6 ± 2.52 kg/m2) or MAD (N=32, 19-61 y, BMI 26.2 ± 3.20 kg/m2); tolerability signals were limited to dose-dependent mild to moderate gastrointestinal events mostly at higher doses. Reductions in postprandial glucose [Day 1 AUC# 12% (p=0.031), Day 5 AUC# 8% (p=0.059)] after an ad libitum diet were observed in 2.0 g BID GLY200 subjects (N=9) as compared to PBO subjects (N=8) in MAD, although reduced food intake may have contributed. Nevertheless, increases in postprandial bile acids [Day 1 AUC† 120% (p=0.002), Day 5 AUC† 70% (p=0.057)] as seen in RYGB were observed suggesting a pharmacological effect. Conclusions: GLY-200 is safe and generally well tolerated. Exploratory PD results are consistent with immediate effects of surgical duodenal exclusion. These results support further development of GLY-200 for the treatment of obesity and T2DM.
  • Publisher: Silver Spring: Blackwell Publishing Ltd
  • Language: English
  • Identifier: ISSN: 1930-7381
    EISSN: 1930-739X
  • Source: ProQuest Central
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