Actively Recruiting
Study to Evaluate if Exposure to Drug is Impacted in Participants With Renal Insufficiency
Led by Sun Pharmaceutical Industries Limited · Updated on 2026-03-13
40
Participants Needed
3
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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 sign informed consent
- Adults aged 18 to 80 years at screening
- Kidney function measured by eGFR in one of these categories: 90 mL/min; 30-59 mL/min; less than 30 mL/min not on dialysis; less than 30 mL/min on intermittent hemodialysis
- Body mass index between 18 and 42 kg/m2
- Female participants of reproductive age willing to use highly effective birth control before and after dosing, or confirmed infertile or post-menopausal
- Male participants agreeing to use highly effective birth control and not donate sperm during and for 30 days after the study
- Willing and able to follow study procedures and visits
- For participants with renal impairment: stable disease status for at least 30 days, renal impairment for at least 3 months, blood pressure between 90-160 mmHg systolic and 110 mmHg diastolic, pulse under 110 bpm
- Stable medication regimen for at least 4 weeks before dosing and during the study
You will not qualify if you...
- Screening calcitonin level 50 ng/L
- On continuous renal replacement therapy or peritoneal dialysis
- Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
- History of acute or chronic pancreatitis
- Taking medications with narrow therapeutic index like digoxin or warfarin
- History of major depressive disorder within 2 years
- Any lifetime suicidal attempt
- Medical conditions that could interfere with study safety or assessments
- Known allergy to study medication or ingredients
- Significant abnormal lab results or uncontrolled disease posing risk
- Positive urine drug screen unless due to prescribed medication (except end-stage renal disease patients without urine output)
- Recent heart attack, unstable angina, or stroke within 6 months
- Clinically significant ECG abnormalities
- Active cancer, except certain treated skin cancers or cancers without recurrence for 5 years
- History of alcohol or drug abuse in past 2 years
- Certain abnormal lab values at screening (liver enzymes, bilirubin, blood counts, coagulation)
- Coagulopathy increasing bleeding risk at injection sites
- Positive tests for HIV, hepatitis B or active hepatitis C
- Participation in another investigational study within 30 days or 5 drug half-lives
- Institutionalization by official orders
- Relationship to Investigator or Sponsor causing conflict of interest
- Any condition judged by Investigator as unacceptable risk or interference with study outcomes
AI-Screening
AI-Powered Screening
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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
CONTACT
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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