GLY-200 / Glyscend - LARVOL DELTA

GLY-200-03: A 16-Week Study to Evaluate the Efficacy, Safety, and Tolerability of GLY-200 in Participants With Obesity (clinicaltrials.gov) - P2 | N=75 | Completed | Sponsor: Glyscend, Inc. | Active, not recruiting ➔ Completed

Trial completion • Genetic Disorders • Obesity

GLY-200 (Oral Duodenal Exclusion Drug) +/- Semaglutide Improves Metabolic Parameters in DIO Mice (OBESITY WEEK 2024) - "In the DIO mouse, chronic (28 days) once-daily treatment with GLY-200 resulted in significant improvements in metabolic parameters compared to control. The combination of GLY-200 and semaglutide had significant improvements compared to semaglutide or GLY-200 alone."

Preclinical • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity

GLY-200-03: A 16-Week Study to Evaluate the Efficacy, Safety, and Tolerability of GLY-200 in Participants With Obesity (clinicaltrials.gov) - P2 | N=75 | Active, not recruiting | Sponsor: Glyscend, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Genetic Disorders • Obesity

GLY-200 (Oral Pharmacologic Duodenal Exclusion Drug) Improves Glycemic Control as Measured by CGM in Patients with Type 2 Diabetes (ADA 2024) - "Improvements in postprandial glucose following standardized mixed-meal challenges and progressive body weight loss were seen in GLY-200 subjects. The Ph2 study was a randomized, double-blind, placebo (PBO)-controlled inpatient study in subjects with T2D washed off metformin, BMI 18-40. As early as Week 1, subjects receiving 2.0 g GLY-200 experienced clinically relevant improvements in both fasting and postprandial glucose as measured with CGM."

Clinical • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

GLY-200 (Oral Pharmacologic Duodenal Exclusion Drug) Decreases Appetite, Increases Satiation, and Reduces Food Intake in Patients with Type 2 Diabetes (ADA 2024) - "Increased satiation/satiety, decreased feeling of hunger, and reduced food intake, in part, explains the body weight loss observed with 2.0 g GLY-200 treatment, consistent with the intended mechanism of the drug."

Clinical • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

GLY-200 (Oral Pharmacologic Duodenal Exclusion Drug) Reduces Glucose and Bodyweight in Patients with Type 2 Diabetes (ADA 2024) - "GLY-200 treatment resulted in positive effects on fasting and postprandial glucose, lipid profiles, food intake, appetite suppression, and BW consistent with the antidiabetic and anti-obesity effects of other more invasive approaches to duodenal exclusion."

Clinical • Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Glyscend Doses First Patient in a Phase 2 Obesity Trial of GLY-200, a First-in-Class Oral Polymeric Drug Candidate for the Treatment of Metabolic Disease (Businesswire) - "Glyscend Therapeutics...today announced the initiation of a Phase 2 clinical trial of its lead candidate, GLY-200....This ongoing Phase 2 trial is designed to evaluate the efficacy, safety, and tolerability of GLY-200 in a non-diabetic obese population....In the ongoing 16-week Phase 2 clinical trial, approximately 70 participants with a BMI between 32 and 40 mg/kg2 will be randomized to receive either 2.0 g GLY-200 or placebo twice-daily for 16 weeks. The primary outcome measures will be percent change in body weight from baseline and the proportion of participants who achieve ≥ 5% body weight reduction at Week 16."

Trial status • Metabolic Disorders • Obesity

GLY-200-03: A 16-Week Study to Evaluate the Efficacy, Safety, and Tolerability of GLY-200 in Participants With Obesity (clinicaltrials.gov) - P2 | N=70 | Recruiting | Sponsor: Glyscend, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Genetic Disorders • Obesity

A 16-Week Study to Evaluate the Efficacy, Safety, and Tolerability of GLY-200 in Participants With Obesity (clinicaltrials.gov) - P2 | N=70 | Not yet recruiting | Sponsor: Glyscend, Inc.

New P2 trial • Genetic Disorders • Obesity

GLY-200 for Duodenal Exclusion (GLYDE Study): Effects of GLY-200 in healthy humans and people with uncomplicated type 2 diabetes. (ANZCTR) - P2 | N=32 | Not yet recruiting | Sponsor: The University of Adelaide

New P2 trial • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus • FGF19

A Study Evaluating the Safety, Tolerability, and Pharmacodynamic Effects of GLY-200 in Type 2 Diabetic Patients (clinicaltrials.gov) - P2 | N=52 | Completed | Sponsor: Glyscend, Inc. | Active, not recruiting ➔ Completed | Trial completion date: Aug 2023 ➔ Mar 2023 | Trial primary completion date: Aug 2023 ➔ Mar 2023

Trial completion • Trial completion date • Trial primary completion date • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Enhancing drought resistance in Pogostemon cablin (Blanco) Benth. through overexpression of ACC deaminase gene using thin cell layer regeneration system. (PubMed, Front Plant Sci) - "A molecular docking study confirmed significant binding affinity of ligand ACC with ACC deaminase at the catalytic site, and ligand interactions showed four H-bonds at the binding pocket with amino acids Cys-196, Val-198, Thr-199, and Gly-200 that validate gene relative expression in transgenic plants...Analysis of the other physiological indicators, HO, chlorophyll content, and ROS result support drought resistance ability. Our study concluded that the first report on P. cablin, tTCL direct regeneration, and standardized transformation protocol created a new opportunity for genetic manipulation to achieve drought-resistant patchouli plants for cultivation in all seasons at the commercial level."

Journal • Gene Therapies • Infectious Disease

GLY-200, a Pharmacologic Duodenal Exclusion Therapy, Improved Metabolic Parameters in the DIO Rat (ADA 2023) - "In the DIO rat, chronic (8-weeks) once-daily treatment with GLY-200 resulted in significant improvements in metabolic parameters compared to saline control consistent with a duodenal exclusion MOA. These results support further development of GLY-200 for the treatment of T2D and obesity."

Preclinical • Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Duodenal Targeting by Oral Pharmacologic Duodenal Exclusion Therapy for Treatment of Type 2 Diabetes (T2D) (ADA 2023) - "Imaging studies confirm that GLY-200 conjugates are retained in the duodenum after oral administration. These data support the hypothesis that GLY-200 treatment results in a pharmacologic duodenal exclusion that could potentially recapitulate the glycemic and weight effects of metabolic surgery and duodenal exclusion devices."

Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Coadministration of Metformin with GLY-200, a Clinical-Stage Nonabsorbed Drug for the Treatment of Type 2 Diabetes (T2D), Has No Significant Impact on the Oral Absorption of Metformin in the Rat (ADA 2023) - "The oral absorption and PK profile of metformin was not significantly altered when the drug was coadministered with GLY-200 or given 1- or 3-hours after a GLY-200 dose. These results suggest that GLY-200 could be used in combination with metformin, whose pharmacologic action is not dependent on Cmax."

Preclinical • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

First-in-Human Study of a Pharmacological Duodenal Exclusion Therapy Mimics a Roux-en-Y Gastric Bypass Biomarker Signature (ADA 2023) - "GLY-200 is safe and generally well tolerated. PD results mimic the biomarker signature observed following RYGB and duodenal exclusion devices, indicating a pharmacological effect in the proximal small intestine."

Bariatric surgery • Biomarker • P1 data • Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

GLY-200, a Pharmacologic Duodenal Exclusion Therapy, Improved Metabolic Parameters in the DIO Rat (ADA 2023) - "In the DIO rat, chronic (8-weeks) once-daily treatment with GLY-200 resulted in significant improvements in metabolic parameters compared to saline control consistent with a duodenal exclusion MOA. These results support further development of GLY-200 for the treatment of T2D and obesity."

Preclinical • Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

First-in-human study of a pharmacological duodenal exclusion therapy shows reduced postprandial glucose and insulin and increased bile acid and gut hormone concentrations. (PubMed, Diabetes Obes Metab) - "GLY-200 is safe and generally well tolerated at doses of ≤2.0 g twice daily. Pharmacodynamic results mimic the biomarker signature observed after Roux-en-Y gastric bypass and duodenal exclusion devices, indicating a pharmacological effect in the proximal small intestine. This study represents the first clinical demonstration that duodenal exclusion can be achieved with an oral drug and supports further development of GLY-200 for the treatment of obesity and/or T2D."

Clinical • Journal • P1 data • Diabetes • Gastrointestinal Disorder • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

A Study Evaluating the Safety, Tolerability, and Pharmacodynamic Effects of GLY-200 in Type 2 Diabetic Patients (clinicaltrials.gov) - P2 | N=52 | Active, not recruiting | Sponsor: Glyscend, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

A molecular dynamics and quantum mechanical investigation of intermolecular interaction and electron-transfer mechanism between copper-containing nitrite reductase and redox partner pseudoazurin. (PubMed, Phys Chem Chem Phys) - "The interactions among the residues Glu89, Gly200, Asp205, Asn91, Glu204, Thr92, and Met141 on CuNiR and the residues Lys109, Ala15, Lys10, Asn9, Ile110, Met84, and Met16 on PAz are responsible for the stabilization of the complex...Additionally, to test whether Met84 may combine with the adjacent Met141 to form a special two-center, three-electron (S∴S) structure to promote the inter-ET, QM/MM was further performed to discuss the possibility of generating an electron stepping stone. Our study will promote a deep understanding of the stable protein-protein interaction, and the identified inter-residue interaction will be theoretical guidance for enhancing the catalytic activity of CuNiR in denitrification."

Journal

Validation of duodenal targeting by oral pharmacologic duodenal exclusion therapy for treatment of type 2 diabetes (EASD 2022) - "Our imaging studies confirm that GLY200 conjugate is effectively retained in the duodenum after oral administration. These observations, along with previously reported glycemic improvements in chronic rodent models of T2DM, support the hypothesis that orally administered polymers designed to target the proximal small intestinal gut wall could potentially be used to non-invasively recapitulate the glycemic and weight effects observed with metabolic surgery and duodenal exclusion devices."

Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Comparing the Efficacy and Safety Profile of Triple Fixed-Dose Combinations in COPD: A Meta-Analysis and IBiS Score. (PubMed, J Clin Med) - "All triple FDCs are effective and safe in COPD regardless of the regimen of administration (twice daily vs. once daily), with no relevant difference in the risk of CV SAEs and pneumonia."

Journal • Retrospective data • Cardiovascular • Chronic Obstructive Pulmonary Disease • Immunology • Infectious Disease • Pneumonia • Pulmonary Disease • Respiratory Diseases

A Study Evaluating the Safety, Tolerability, and Pharmacodynamic Effects of GLY-200 in Type 2 Diabetic Patients (clinicaltrials.gov) - P2 | N=48 | Recruiting | Sponsor: Glyscend, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

A Study Evaluating the Safety, Tolerability, and Pharmacodynamic Effects of GLY-200 in Type 2 Diabetic Patients (clinicaltrials.gov) - P2 | N=48 | Not yet recruiting | Sponsor: Glyscend, Inc.

New P2 trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus