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RECRUITING Phase 2

Efficacy and Safety of GL0034 in Overweight or Obese Adults With Type II Diabetes Mellitus

NCT07282743 · View on ClinicalTrials.gov ↗

Study Summary

This is a phase II, randomized, double-blind, placebo-controlled study to evaluate the efficacy and tolerability of GL0034 among type II diabetes mellitus subjects who are obese or overweight with weight-related comorbidities. Subjects will be put on either one of the four treatment arms (GL0034, once a week, subcutaneous injection) or placebo arm (once a week, subcutaneous injection) following initial dose-up titration that takes up to approximately 20 weeks. The primary end point is change in HbA1c levels from baseline (Week 0) to Week 36 following treatments in all participants.

Conditions Studied

Interventions

  • DRUG GL0034 Dose Level 1
  • DRUG GL0034 Dose Level 2
  • DRUG GL0034 Dose Level 3
  • DRUG GL0034 Dose Level 4
  • DRUG GL0034 Dose Level 5

Study Locations (20)

Florida

  • Family First Medical Research Center — Hialeah Gardens
  • Alliance for Multispecialty Research (AMR Clinical) - Wichita East — Lakeland
  • CNS Healthcare - Memphis (Clinical Neuroscience Solutions - Memphis) — Lakeland
  • GTL Medical & Research Group — Miami
  • Florida Institute for Clinical Research LLC — Orlando

Maharashtra

  • Nirmal Hospital Private Limited — Kolhāpur
  • Topiwala National Medical College & BYL Nair Hospital — Mumbai
  • Seth G. S. medical college and KEM hospital — Mumbai
  • BSES Municipal General Hospital — Mumbai
  • LMMF's Deenanath Mangeshkar Hospital and Research Center — Pune

Kansas

  • AMR Clinical, El Dorado — El Dorado
  • AMR Clinical - Newton — Newton

Kerala

  • Government Medical College — Kozhikode
  • Jothydevs Diabetes Research Centre — Trivandrum

National Capital Territory of Delhi

  • Lady Hardinge Medical College and S.S.K. Hospital — New Delhi
  • All India Institute of Medical Sciences — New Delhi

Arkansas

  • Lynn Institute of the Ozarks — Little Rock

Oklahoma

  • Lynn Health Science Institute - Oklahoma City — Oklahoma City

Andhra Pradesh

  • Endolife Specialty Hospitals Pvt. Ltd. — Guntur

Trial Details

FieldValue
Enrollment Target 285 participants
Start Date 2026-01-20
Est. Completion 2027-08
Phase Phase 2

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07282743

The ClinicalTrials.gov registry entry for NCT07282743 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 285 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sun Pharmaceutical Industries Limited, which has 13 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Type II Diabetes Mellitus appearing as the primary indexed condition, and to 5 interventions — of which GL0034 Dose Level 1 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT07282743 reports 20 study locations spanning 9 distinct geographic areas — top geographies include Florida, Maharashtra, Kansas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT07282743 about?

NCT07282743 is a clinical study titled "Efficacy and Safety of GL0034 in Overweight or Obese Adults With Type II Diabetes Mellitus". This is a phase II, randomized, double-blind, placebo-controlled study to evaluate the efficacy and tolerability of GL0034 among type II diabetes mellitus subjects who are obese or overweight with weight-related comorbidities. Subjects will be put on either one of the four treatment arms (GL0034, on...

What is the current status of trial NCT07282743?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 285 participants. The study started on 2026-01-20. Estimated completion is 2027-08.

What conditions does trial NCT07282743 study?

This clinical trial studies the following conditions: Type II Diabetes Mellitus. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT07282743?

The interventions under investigation include: GL0034 Dose Level 1 (DRUG), GL0034 Dose Level 2 (DRUG), GL0034 Dose Level 3 (DRUG), GL0034 Dose Level 4 (DRUG), GL0034 Dose Level 5 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT07282743?

This trial is sponsored by Sun Pharmaceutical Industries Limited, which has 13 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT07282743 being conducted?

This trial has 20 study locations across Arkansas, Florida, Kansas, Oklahoma, Andhra Pradesh. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial