Study of GL0034 for Type 2 Diabetes and Kidney Function
This study is looking at how a single dose of GL0034, a medication for Type 2 Diabetes, is processed in the body of people with different levels of kidney function. We want to see if kidney problems affect how much of the drug stays in your system. We are enrolling about 40 adults, aged 18 to 80, who have Type 2 Diabetes and varying degrees of kidney function, including those on dialysis. You would receive one dose of GL0034 under the skin. We will measure the levels of GL0034 in your blood over time to understand its effects. This will help doctors know the best way to give GL0034 to patients with kidney issues. The study's current status is unclear.
- Study design
- This is an open-label, single-dose, Phase 1 study. Approximately 40 adult participants will be enrolled across four groups based on their kidney function.
- What's involved
- You would receive a single subcutaneous (under the skin) dose of GL0034. Blood samples will be collected at multiple time points from before the dose through 672 hours (28 days) after the dose.
- Compensation
- Not stated in the trial record.
- Follow-up
- Blood samples will be collected for up to 672 hours (28 days) after you receive the dose.
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NCT07385547
Study to Evaluate if Exposure to Drug is Impacted in Participants With Renal Insufficiency
Recruiting
PHASE1Ages 18–80InterventionalTreatmentSun Pharmaceutical Industries Limited
~40 participants
Updated 2026-03-13 on ClinicalTrials.gov
What's tested:GL0034
At a glance
Recruiting sites
1 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Single dose PK exposure parameters: Maximum concentration (Cmax)
Measured over From predose through 672 hours post-dose (multiple time points)
+2 more outcomes measured
Conditions
Where it's being run
3 sites across 1 statesFlorida3
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
eGFR ≥ 90 mL/min;
eGFR ≥ 30-59 mL/min;
eGFR \< 30 mL/min, not on dialysis;
eGFR \< 30 mL/min, on intermittent hemodialysis. 4. Participant has a body mass index ≥ 18 kg/m2 and ≤ 42 kg/m2 at the Screening visit. 5. Contraception requirements:
Exclusion
Participant has a history of basal cell or in-situ squamous cell carcinoma of skin that has been adequately treated and resolved, per Investigator's judgement.
Participant has a history of other malignancy that have been adequately treated with no evidence of recurrence/relapse within the last 5 years, per Investigator's judgement. 15. Participant has a history of alcohol or drug abuse in the previous two years. 16. Participant has any of the following laboratory abnormalities at Screening:
Aspartate aminotransferase or alanine aminotransferase ≥ 3 times the upper limit of normal.
Serum total bilirubin ≥ 1.5 mg/dL (Note: participants with elevated total bilirubin which, as per Investigator's clinical judgement, is thought to be due to Gilbert's syndrome may be included).
White blood cell count \< 3.0 x 103/μL.
International normalized ratio (INR) ≥ 1.3.
Hemoglobin \< 11.0 g/dL in participants with normal renal function or hemoglobin \< 9.0 g/dL in participants with moderate or severe renal impairment. 17. Participant has a known history of coagulopathy such that SC injection will result in excessive bleeding at the injection sites. 18. Participant has a positive serology for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C. A participant who is hepatitis C virus (HCV) antibody negative can be included in the study. A participant with positive HCV antibodies shall be tested for HCV-ribonucleic acid (RNA). If tested negative, the participant can be included in the study. 19. Participant participated in another interventional study or received another investigational drug/device/biologic within 30 days or 5 half-lives (whichever is longer) of study intervention. 20. Participant has been placed in an institution on official or judicial orders. 21. Participant is related to or dependent on the Investigator, Sponsor, or study site such that a conflict of interest may arise. 22. Participant has any condition, which, in the opinion of the Investigator, precludes participation in the study (either poses an unacceptable risk to the participant or interferes with assessment/interpretation of study outcomes).
What this trial measures
- Single dose PK exposure parameters: Maximum concentration (Cmax)From predose through 672 hours post-dose (multiple time points)
- Single dose PK exposure parameters: Area under the plasma concentration-time curve (AUC) from time zero to the time of the last quantifiable concentration (AUC0-t)From predose through 672 hours post-dose (multiple time points)
- Single dose PK exposure parameters: AUC from time zero extrapolated to infinite time (AUC0-i)From predose through 672 hours post-dose (multiple time points)