A Study Evaluating the Safety, Tolerability, and Pharmacodynamic Effects of GLY-200 in Type 2 Diabetic Patients

NCT05478525 | Completed Phase 2 Results FDA Drug

• 1 other identifier: GLY-200-02
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a Phase 2, randomized, double-blind, placebo-controlled, single-center study in adult patients with type 2 diabetes. It will evaluate the safety and tolerability of oral GLY-200. Subjects will participate in a ≤ 18-day screening period followed by a metformin washout period of approximately 14 days, and an inpatient period of 16 days. Approximately 48 subjects will be randomized to 1 of 3 active treatment groups or 1 of 3 placebo groups. Dosing will occur for 14 days. A follow-up clinic visit will occur on Day 21 \[End of Study (EOS)\] or Early Termination (ET).

Conditions

Type 2 Diabetes

Keywords

Type 2 Diabetes; Diabetes Mellitus, Type 2; GLY-200; Glyscend, Inc.

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events [Safety and Tolerability of GLY-200]

  Safety and tolerability will be assessed by incidence of adverse events (AEs). Clinically significant changes from baseline in vital signs, clinical laboratory parameters, and electrocardiograms (ECGs) will be recorded as AEs.

  Over the 14-day treatment period

Secondary Outcomes (4)

• Change From Baseline in Fasting Glucose

  Day 1, Day 7, and Day 14

• Change From Baseline in Fasting Plasma Insulin

  Day 1, Day 7, and Day 14

• Change From Baseline in 3-hours Postprandial Plasma Glucose Profile

  Day 1, Day 7, and Day 14

• Change From Baseline in 3-hours Postprandial Plasma Insulin Profile

  Day 1, Day 7, and Day 14

Study Arms (6)

0.5 g GLY-200

EXPERIMENTAL

0.5 g GLY-200 (1 x 0.5 g capsule) twice a day (BID)

Drug: GLY-200

1.0 g GLY-200

EXPERIMENTAL

1.0 g GLY-200 (2 x 0.5 g capsule) twice a day (BID)

Drug: GLY-200

2.0 g GLY-200

EXPERIMENTAL

2.0 g GLY-200 (4 x 0.5 g capsule) twice a day (BID)

Drug: GLY-200

Placebo for 0.5 g GLY-200 arm

PLACEBO COMPARATOR

1 placebo capsule twice a day (BID)

Drug: Placebo

Placebo for 1.0 g GLY-200 arm

PLACEBO COMPARATOR

2 placebo capsules twice a day (BID)

Drug: Placebo

Placebo for 2.0 GLY-200 arm

PLACEBO COMPARATOR

4 placebo capsules twice a day (BID)

Drug: Placebo

Interventions

GLY-200 DRUG

0.5 g GLY-200 (1 x 0.5 g capsule) BID for 14 days (n=12)

0.5 g GLY-200

Placebo DRUG

1 placebo capsule BID for 14 days (n=4)

Placebo for 0.5 g GLY-200 arm

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with type 2 diabetes: hemoglobin A1c (HbA1c)) ≥ 6.0 and ≤ 8.5% at screening
• Body mass index (BMI) ≥ 18 and ≤ 40 at screening

You may not qualify if:

• Treated with any prescription medication for the treatment of type 2 diabetes or weight loss other than metformin in the last 3 months prior to screening
• Use of any drug treatment that affects gastric pH
• Use of any drug treatment that affects gastrointestinal motility
• Fasting blood glucose \> 190 mg/dL
• Diagnosis or treatment of any clinically symptomatic biochemical or structural abnormality of the gastrointestinal (GI) tract or active disease within 12 months prior to screening
• History of any previous abdominal or intestinal surgery including endoscopic, open or laparoscopic thoracic or abdominal surgery, surgical resection of the stomach, small or large intestine
• Clinically significant medical condition as judged by the Investigator that could potentially affect study participation and/or personal well-being

Sponsors & Collaborators

• Glyscend, Inc.: lead

Study Sites (1)

ProSciento, Inc.

Chula Vista, California, 91911, United States

Location

Related Publications (1)

• Bryant CLN, Colbert K, Hompesch M, Chaves S, Nimgaonkar A, Fineman MS. GLY-200, an oral pharmacologic duodenal exclusion drug, resulted in positive effects on glucose, lipids and bodyweight in patients with type 2 diabetes: Results of a randomized, double-blind placebo-controlled trial. Diabetes Obes Metab. 2025 Oct;27(10):5996-6005. doi: 10.1111/dom.16664. Epub 2025 Aug 6.

  PMID: 40767317 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Ashish Nimgaonkar, MD
• Organization: Glyscend Therapeutics

ashish.nimgaonkar@gmail.com

6175483513

Study Officials

• Mark Fineman, PhD

  Glyscend, Inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2022
• First Posted: July 28, 2022
• Study Start: August 3, 2022
• Primary Completion: March 14, 2023
• Study Completion: March 14, 2023
• Last Updated: February 10, 2025
• Results First Posted: February 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)