Actively Recruiting
A Phase 1 Study to Assess the Effect of Renal Impairment on the Pharmacokinetics of GL0034
Led by Sun Pharmaceutical Industries Limited · Updated on 2026-03-13
40
Participants Needed
3
Research Sites
3 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating how kidney problems affect the way the body processes GL0034, a long-acting drug used for Type II Diabetes Mellitus. This Phase 1 open-label study will include about 40 adults with varying levels of kidney function, including those with normal kidneys and those with moderate to severe kidney impairment, some on dialysis. The goal is to understand if kidney health changes the drug levels in the body and to guide safe dosing for patients with kidney issues. Participants will receive a single subcutaneous dose of GL0034. They will be grouped based on kidney function: normal, moderate impairment, severe impairment without dialysis, and severe impairment with dialysis. Blood samples will be taken at multiple times over 672 hours after dosing to study the drug’s presence in the body. The study will also watch for any side effects or safety concerns during the trial. During the study, participants will undergo blood sampling to measure drug levels and safety checks up to five weeks after dosing. Researchers will monitor for any adverse events or serious side effects. The total study participation involves screening, dosing, multiple blood draws, and follow-up visits to assess how the drug behaves in people with different kidney functions and to ensure their safety throughout the trial.
CONDITIONS
Brief Title
Study to Evaluate if Exposure to Drug is Impacted in Participants With Renal Insufficiency
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide informed consent
- Adult male or female aged 18 to 80 years inclusive at screening
- eGFR within one of these ranges: 90 mL/min or higher; 30-59 mL/min; less than 30 mL/min without dialysis; less than 30 mL/min with intermittent hemodialysis
- Body mass index between 18 and 42 kg/m2 at screening
- Female participants of reproductive age must use highly effective birth control starting 4 weeks before and continuing 30 days after dosing
- Male participants must use highly effective contraception with partners from baseline until 30 days after final dose and not donate sperm during this time
- Willing and able to comply with study procedures and schedule
- Stable renal impairment for at least 3 months with no significant change in disease status within 30 days before screening
- Blood pressure between 90-160 mmHg systolic and not higher than 110 mmHg diastolic after resting supine
- Stable dose of medication for underlying diseases related to renal impairment for at least 4 weeks before dosing and during the study
You will not qualify if you...
- Screening calcitonin level 50 ng/L or higher
- On continuous renal replacement therapy or peritoneal dialysis
- Personal or family history of medullary thyroid carcinoma or MEN syndrome type 2
- History of acute or chronic pancreatitis
- Taking medications with a narrow therapeutic index such as digoxin or warfarin
- History of major depressive disorder within 2 years before randomization
- Any lifetime history of suicide attempt
- Any medical condition that may affect study safety or assessments as judged by the Investigator
- Known allergy to study drug or its components
- Clinically significant abnormal lab values or uncontrolled disease involving major organs
- Positive urine drug screen unless due to prescribed medication (waived for ESRD with no urine output)
- Recent myocardial infarction, unstable angina, or ischemic stroke within 6 months
- Clinically significant ECG abnormalities
- Active malignancy (some treated past cancers may be allowed)
- History of alcohol or drug abuse in last 2 years
- Liver enzyme levels 3 times above normal or high bilirubin (except Gilbert's syndrome)
- Low white blood cell count or low hemoglobin below defined thresholds
- Known bleeding disorders making injections unsafe
- Positive HIV, hepatitis B, or hepatitis C serology (with some exceptions for HCV)
- Participation in another investigational study within 30 days or 5 half-lives
- Institutionalization under official or judicial orders
- Related to or dependent on the Investigator, Sponsor, or study site
- Any condition that poses unacceptable risk or interferes with study as judged by Investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 28 days
Participants receive a single subcutaneous dose of GL0034 to assess drug exposure in relation to renal function.
Multiple visits over 28 days for drug administration and monitoring
Duration - Up to 5 weeks
Participants are monitored for adverse events and safety up to 5 weeks after dosing.
Approximately 1 to 2 follow-up visits
Trial Site Locations
Total: 3 locations
1
Syneos Miami
Miami, Florida, United States, 33136
Not Yet Recruiting
2
Panax Clinical Research
Miami Lakes, Florida, United States, 33014
Actively Recruiting
3
Orlando Clinical Research Center (OCRC)
Orlando, Florida, United States, 32809
Not Yet Recruiting
Research Team
H
Head Regulatory Affairs
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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