GL0034 for Type 2 Diabetes
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests GL0034, a long-acting treatment for type 2 diabetes, to evaluate its effects in individuals with varying kidney function levels. Researchers aim to determine whether kidney problems alter how the body processes the drug and to assess its safety and tolerability. Individuals with kidney issues lasting at least three months and stable symptoms may qualify for this study. This research will inform future dosing recommendations for those with kidney impairments. As a Phase 1 trial, it focuses on understanding the treatment's effects in people, providing participants the opportunity to be among the first to receive this new treatment.
Is there any evidence suggesting that GL0034 is likely to be safe for humans?
Research has shown that GL0034 is generally well tolerated. In studies involving adults with type 2 diabetes and obesity, GL0034 appeared safe. Most side effects were mild and primarily involved the stomach, such as nausea and vomiting. These side effects occurred more frequently with higher doses but typically improved over time.
Positive effects included weight loss and improvements in liver function and cholesterol levels. These findings suggest that GL0034 is safe, but the current trial will provide more details about its safety for individuals with varying kidney function levels.12345Why do researchers think this study treatment might be promising for Type 2 Diabetes?
GL0034 is unique because it offers a single-dose treatment option for Type 2 Diabetes, which could simplify management for patients compared to the multiple daily doses required by many current therapies like metformin or insulin. Researchers are excited about GL0034 because it potentially introduces a new mechanism of action that targets blood sugar regulation in a novel way. This innovative approach could lead to more effective control of blood sugar levels with fewer side effects, making diabetes management easier and more efficient for patients.
What evidence suggests that GL0034 might be an effective treatment for Type 2 Diabetes?
Research has shown that GL0034, also known as utreglutide, is a promising treatment for type 2 diabetes. In previous studies, it significantly reduced body weight by 6.8% and improved cholesterol levels. GL0034 activates certain receptors in the body, helping to lower blood sugar and enhance overall health. Early results also indicate it can lead to significant weight loss and improved fat levels in people with obesity. These findings suggest that GL0034 may effectively manage type 2 diabetes and related conditions. Participants in this trial will receive a single dose of GL0034 to further evaluate its effectiveness.16789
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single subcutaneous dose of GL0034
Follow-up
Participants are monitored for safety and pharmacokinetics after receiving the dose
What Are the Treatments Tested in This Trial?
Interventions
- GL0034
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Single dose of GL0034
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sun Pharmaceutical Industries Limited
Lead Sponsor
Dilip Shanghvi
Sun Pharmaceutical Industries Limited
Chief Executive Officer since 1993
Majored in Cellular and Molecular Biology at the University of Michigan – Ann Arbor
Dr. Azadar H. Khan
Sun Pharmaceutical Industries Limited
Chief Medical Officer since 2023
MD from a recognized institution
Citations
Efficacy and Safety of GL0034 in Overweight or Obese ...
This is a phase II, randomized, double-blind, placebo-controlled study to evaluate the efficacy and tolerability of GL0034 among type II diabetes mellitus ...
2.
diabetesjournals.org
diabetesjournals.org/diabetes/article/74/Supplement_1/759-P/160520/759-P-Effects-of-Once-Weekly-Utreglutide-GL0034-in759-P: Effects of Once-Weekly Utreglutide (GL0034) in ...
Results: At visit 11, BW reduction after UTG treatment was 6.8%; leptin, LDL, apolipoprotein B, total cholesterol, non-HDL and hs-CRP were ...
Sun Pharma Presents Data from Phase 1b/ ...
GL0034 (utreglutide) is an investigational novel glucagon-like peptide 1 receptor agonist (GLP-. 1RA) in development as a once-weekly, long- ...
Sun Pharma Presents Data from First-in-Human Phase 1 ...
"GL0034 has a promising future in terms of weight loss and glycemic effects and based on these early results presented at ADA, GL0034 has a ...
In vivo and in vitro characterization of GL0034, a novel long ...
Insulin secretory responses were similar for both ligands. GL0034 (6 nmol/kg) led to at least as much weight loss and lowering of blood glucose as did ...
ADA-GL0034-Data-Release_FINAL_Formatted. ...
“Initial results showed that. GL0034 was generally well tolerated, and we are encouraged by the rate and durability of weight loss in these ...
7.
clinicaltrials.eu
clinicaltrials.eu/trial/study-on-the-safety-and-effectiveness-of-utreglutide-gl0034-for-adults-with-type-2-diabetes-not-well-managed-with-metformin-or-lifestyle-changes/Study on the Safety and Effectiveness of Utreglutide ...
The purpose of the study is to investigate the safety and tolerability of GL0034 over a period of 16 weeks in adults with Type 2 diabetes who have not achieved ...
Sun Pharma's GL0034 (Utreglutide) Demonstrates ...
The recent GL0034 study has shown encouraging results with significant weight loss and notable improvements in lipid profiles among obese participants.
Abstract 4116298: Once Weekly Utreglutide (GL0034), a ...
Results: Utreglutide was generally well tolerated and related adverse effects were mainly gastrointestinal with dose-dependent nausea, vomiting ...
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