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NCT07385547 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate if Exposure to Drug is Impacted in Participants With Renal Insufficiency
A Phase 1 study of Type II Diabetes Mellitus, sponsored by Sun Pharmaceutical Industries Limited.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
- 3
- Study locations
NCT07385547: Recruiting Phase 1 study of Type II Diabetes Mellitus, sponsored by Sun Pharmaceutical Industries Limited.
NCT07385547 is a Phase 1 study of Type II Diabetes Mellitus that is actively recruiting participants, run by Sun Pharmaceutical Industries Limited. The registered enrollment target is 40 participants, below the 168-participant average among 7 other Type II Diabetes Mellitus trials with a reported enrollment target (76% lower). The trial reports 3 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07385547, a Phase 1 study of Type II Diabetes Mellitus, is actively recruiting participants, sponsored by Sun Pharmaceutical Industries Limited.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
- 3
- Study locations
Study Summary
This is an open-label, single-dose, Phase 1 clinical study designed to evaluate the effect of renal impairment on the pharmacokinetics (PK) of GL0034, a long-acting GLP-1 receptor agonist. Approximately 40 adult participants will be enrolled across four groups: normal renal function, moderate renal impairment, severe renal impairment without dialysis, and severe renal impairment with dialysis. Each participant will receive a single subcutaneous dose of GL0034. Blood samples will be collected for PK analysis. Secondary objectives include assessing safety and tolerability. The study will help determine whether renal impairment affects GL0034 exposure and inform dosing recommendations for patients with compromised renal function.
Conditions Studied
Interventions
- DRUG GL0034
Study Locations (3)
Florida
- Syneos Miami - Miami
- Panax Clinical Research - Miami Lakes
- Orlando Clinical Research Center (OCRC) - Orlando
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2026-02-25 |
| Est. Completion | 2026-09-27 |
| Phase | Phase 1 |
What NCT07385547 shows while recruiting
NCT07385547 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 168-participant average among 7 other Type II Diabetes Mellitus trials with a reported enrollment target (76% lower).
The record links to 1 condition, with Type II Diabetes Mellitus appearing as the primary indexed condition, and to 1 intervention - of which GL0034 is the first listed.
NCT07385547 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT07385547 about?
NCT07385547 is a clinical study titled "Study to Evaluate if Exposure to Drug is Impacted in Participants With Renal Insufficiency". This is an open-label, single-dose, Phase 1 clinical study designed to evaluate the effect of renal impairment on the pharmacokinetics (PK) of GL0034, a long-acting GLP-1 receptor agonist. Approximately 40 adult participants will be enrolled across four groups: normal renal function, moderate renal ...
What is the current status of trial NCT07385547?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2026-02-25. Estimated completion is 2026-09-27.
What conditions does trial NCT07385547 study?
This clinical trial studies the following conditions: Type II Diabetes Mellitus.
What interventions are being tested in trial NCT07385547?
The interventions under investigation include: GL0034 (DRUG).
Who is sponsoring clinical trial NCT07385547?
This trial is sponsored by Sun Pharmaceutical Industries Limited, which has 38 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07385547 being conducted?
This trial has 3 study locations across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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