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2024-513279-41-00CompletedPhase 2

A Phase 2 Parallel Group Study in Adults with Type 2 Diabetes to evaluate Efficacy and Safety of GL0034

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Once Weekly s.c. Administered GL0034 in Adults with Type 2 Diabetes Mellitus Inadequately controlled on Metformin Or Diet and Exercise

Source: EU CTIS (euclinicaltrials.eu) · Last updated 10 Nov 2025

Next steps

Brief summary (registry, in English)

To investigate safety and tolerability of GL0034 with different titration algorithms over 16 weeks of treatment in people with type 2 diabetes.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
60 (actual)
First submitted
24 May 2024
Start date
6 Sept 2024
Lead sponsor
Sun Pharmaceutical Industries Limited
EU CT number
2024-513279-41-00

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 60
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Exposure to semaglutide, or other Glucagon-like-peptide 1 receptor (GLP-1R) agonists (including combination products) within 3 months prior to screening
  • Any additional oral anti-hyperglycemic drugs beyond metformin and/ or a SGLT-2-inhibitor within 3 months prior to screening

Other illness

  • Were diagnosed with type 1 diabetes mellitus
  • Had known allergies to GLP-1 analogs, GIP + GLP-1 analogs, glucagon, or related compounds

Lab values

  • Have a history of acute or chronic pancreatitis or fasting serum triglyceride level of >5.65 mmol/L at screening and/or Day -1. If participant is on lipid-lowering therapies, doses must be stable for 30 days prior to screening

Other

  • Women who are pregnant, nursing, or who plan to become pregnant while in the trial

Who the study is looking for

  • Male and female patients 18 years to 70 years (both inclusive) of age on the day of signing informed consent
  • Diagnosis of Type 2 diabetes mellitus (T2DM) at least 6 months prior to informed consent
  • Have a glycated hemoglobin (HbA1c) value at screening of >= 6.5% and <=8.5% and treated with diet and exercise alone or a stable dose of metformin and/ or a SGLT-2-inhibitor for at least 3 months prior to screening
  • Have a body mass index of >=28 to <=50 kilograms per square meter (kg/m²), both are inclusive

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (2)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
CRS Clinical Research Services Mannheim GmbHMannheimGermanyCompleted
PROFIL Institut fuer Stoffwechselforschung GmbHNeussGermanyCompleted

Are you the coordinator? Confirm the details

This page is information, not medical advice. Discuss any trial with your doctor.