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

NCT07385547 | Recruiting Phase 1 FDA Drug

• 1 other identifier: UTRE-25-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

Brief Summary

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

Type II Diabetes Mellitus

Outcome Measures

Primary Outcomes (3)

• 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)

Secondary Outcomes (1)

• Adverse events (AEs) leading to trial discontinuation and serious adverse events (SAEs).

  Week 5

Study Arms (1)

GL0034

EXPERIMENTAL

Single dose of GL0034

Drug: GL0034

Interventions

GL0034 DRUG

Subcutaneous (SC) administration of a single dose of GL0034

GL0034

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant is willing and able to sign a written or electronic informed consent.
• Participant is an adult male or female, aged between 18 and 80 years of age, inclusive, at the time of screening.
• 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.
• Participant has a body mass index ≥ 18 kg/m2 and ≤ 42 kg/m2 at the Screening visit.
• Contraception requirements:
• Female participants must:
• If of reproductive age and sexually active, be willing and able to use a medically highly effective form of birth control 4 weeks prior to and for 30 days following the dose of trial medication. Examples of medically highly effective forms of birth control are:
• Confirmed infertility due to surgical procedure or post-menopausal (cessation of menses for at least 12 months prior to Screening).
• Confirmed infertility of sexual partner or partner of the same sex.
• Hormonal contraceptive (oral, combined, patch, vaginal ring, injectable, implant) in females.
• Double-barrier method (any combination of physical and chemical methods).

You may not qualify if:

• Participant has a screening calcitonin ≥ 50 ng/L (pg/mL).
• Participant is on continuous renal replacement therapy or peritoneal dialysis.
• Participant has a personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome (MENS) type 2.
• Participant has a history of pancreatitis (acute or chronic).
• Participant is taking medications with a narrow therapeutic index such as digoxin, warfarin, etc.
• Participant has a history of major depressive disorder within 2 years before randomization.
• Participant has any lifetime history of a suicidal attempt.
• Participant has any medical condition that, in the opinion of the Investigator, can confound study assessments or safety concerns.
• Participant has a known hypersensitivity to the study medications or excipients.
• Participant has clinically significant abnormal values on Screening laboratory tests or other evidence of uncontrolled disease involving any system-organ (e.g., cardiovascular, pulmonary, hepatic, neurological, endocrine, GI, psychiatric, etc.) that, in the opinion of the Investigator, would put the participant at risk by participating in the study.
• Participant has a positive urine drug screen (amphetamine, barbiturate, benzodiazepine, cocaine, opiates, tetrahydrocannabinols). A positive test is allowed in case the participant receives a prescription drug responsible for the positive test. Waived for ESRD participants with no urine output.
• Participant had a myocardial infarction, unstable angina pectoris, or ischemic stroke within the past 6 months prior to investigational product administration.
• Participant has a clinically significant ECG abnormality as judged by the Investigator.
• Participant has an active malignancy.
• Note: participants with past history of malignancy may be included if:

Sponsors & Collaborators

• Sun Pharmaceutical Industries Limited: lead

Study Sites (3)

Syneos Miami

Miami, Florida, 33136, United States

NOT YET RECRUITING

Panax Clinical Research

Miami Lakes, Florida, 33014, United States

RECRUITING

Orlando Clinical Research Center (OCRC)

Orlando, Florida, 32809, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Head Regulatory Affairs

CONTACT

9122 66455645; Clinical.Trial@sunpharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2026
• First Posted: February 4, 2026
• Study Start: February 25, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 27, 2026
• Last Updated: March 13, 2026

Record last verified: 2026-03

Locations

US (3)