Study to Evaluate if Exposure to Drug is Impacted in Participants With Renal Insufficiency

Recruiting Phase 1 Interventional Study
Type II Diabetes Mellitus
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
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At a Glance
Age
18 – 80
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
40 (estimated)
Sponsor
Sun Pharmaceutical Industries Limited · Industry
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About This Trial
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. Eac…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 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 u…
Contacts

Head Regulatory Affairs

9122 66455645

Clinical.Trial@sunpharma.com

CONTACT