Study to Evaluate if Exposure to Drug is Impacted in Participants With Renal Insufficiency
Eligible age
18–80 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
Yes
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About this study
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.
Sponsor: Sun Pharmaceutical Industries Limited
You may qualify if…
- ✓ 1. Participant is willing and able to sign a written or electronic informed consent.
- ✓ 2. Participant is an adult male or female, aged between 18 and 80 years of age, inclusive, at the time of screening.
- ✓ 3. Participant has eGFR as defined by CKD-EPI equation and converted to the unit of mL/min according to the following ranges:
- ✓ 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.
You may not qualify if…
- ✕ 1. Participant has a screening calcitonin ≥ 50 ng/L (pg/mL).
- ✕ 2. Participant is on continuous renal replacement therapy or peritoneal dialysis.
- ✕ 3. Participant has a personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome (MENS) type 2.
- ✕ 4. Participant has a history of pancreatitis (acute or chronic).
- ✕ 5. Participant is taking medications with a narrow therapeutic index such as digoxin, warfarin, etc.
- ✕ 6. Participant has a history of major depressive disorder within 2 years before randomization.
- ✕ 7. Participant has any lifetime history of a suicidal attempt.
- ✕ 8. Participant has any medical condition that, in the opinion of the Investigator, can confound study assessments or safety concerns.
Where it's recruiting
Miami · Miami Lakes · Orlando
Source: ClinicalTrials.gov · NCT07385547 · last updated 2026-03-13