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Type II Diabetes MellitusPhase 1NCT07385547

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

A Phase 1 study testing GL0034 in people with Type II Diabetes Mellitus, run by Sun Pharmaceutical Industries Limited at 3 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Type II Diabetes Mellitus
What is being tested?
GL0034
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
3 sitesUnited States
Study dates
25 Feb 2026to 27 Sep 2026
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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).
  • Intrauterine device with a failure rate less than 1% per year.
  • Male participants must:
  • Agree to use, with their partners, one of the highly effective contraceptive methods, from Baseline until at least 30 days following last dose of trial drug.
  • Refrain from donating sperm during the trial and for at least 30 days after the end of the trial.
  • Participant is willing and able to comply with the study protocol, visit schedule, and other study-related instructions and procedures.
  • Participants with Renal Impairment
  • The participant must have no clinically significant change in disease status within the last 30 days before screening, as documented by the participant's recent medical history.
  • The participant must have a condition consistent with renal impairment, for at least 3 months, and associated symptoms, but otherwise be determined to be in good health in the opinion of the Investigator.
  • The participant must have blood pressure (after the participant is supine for at least 5 minutes) between 90 and 160 mmHg systolic, inclusive, and not higher than 110 mmHg diastolic. If blood pressure is out of range, up to 2 repeated assessments are permitted at Screening and check-in. Pulse should not be higher than 110 beats per minute (bpm).
  • Concomitant medications to treat underlying disease states or medical conditions related to renal impairment are allowed, however must be on a stable dose of medication and/or treatment regimen for at least 4 weeks before dosing as well as during the study.

Who cannot join

  • 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.
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  • 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:
  • Participant has a history of basal cell or in-situ squamous cell carcinoma of skin that has been adequately treated and resolved, per Investigator's judgement.
  • Participant has a history of other malignancy that have been adequately treated with no evidence of recurrence/relapse within the last 5 years, per Investigator's judgement.
  • Participant has a history of alcohol or drug abuse in the previous two years.
  • Participant has any of the following laboratory abnormalities at Screening:
  • Aspartate aminotransferase or alanine aminotransferase ≥ 3 times the upper limit of normal.
  • Serum total bilirubin ≥ 1.5 mg/dL (Note: participants with elevated total bilirubin which, as per Investigator's clinical judgement, is thought to be due to Gilbert's syndrome may be included).
  • White blood cell count < 3.0 x 103/μL.
  • International normalized ratio (INR) ≥ 1.3.
  • Hemoglobin < 11.0 g/dL in participants with normal renal function or hemoglobin < 9.0 g/dL in participants with moderate or severe renal impairment.
  • Participant has a known history of coagulopathy such that SC injection will result in excessive bleeding at the injection sites.
  • Participant has a positive serology for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C. A participant who is hepatitis C virus (HCV) antibody negative can be included in the study. A participant with positive HCV antibodies shall be tested for HCV-ribonucleic acid (RNA). If tested negative, the participant can be included in the study.
  • Participant participated in another interventional study or received another investigational drug/device/biologic within 30 days or 5 half-lives (whichever is longer) of study intervention.
  • Participant has been placed in an institution on official or judicial orders.
  • Participant is related to or dependent on the Investigator, Sponsor, or study site such that a conflict of interest may arise.
  • Participant has any condition, which, in the opinion of the Investigator, precludes participation in the study (either poses an unacceptable risk to the participant or interferes with assessment/interpretation of study outcomes).

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Head Regulatory Affairs contact

9122 66455645 ext. 5789

Clinical.Trial@sunpharma.com

United States3 sites, 3 recruiting

  • Syneos Miami

    Miami, Florida, 33136

    Not yet recruiting

  • Panax Clinical Research

    Miami Lakes, Florida, 33014

    Recruiting

  • Orlando Clinical Research Center (OCRC)

    Orlando, Florida, 32809

    Not yet recruiting

Other trials in United States

About this study

Official title: A Phase 1 Study to Assess the Effect of Renal Impairment on the Pharmacokinetics of GL0034

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.

Being tested
GL0034
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GL0034Drug

    Subcutaneous (SC) administration of a single dose of GL0034

Study groups in NCT07385547
Study groupRoleWhat they receive
GL0034ExperimentalSingle dose of GL0034
Receives: Drug: GL0034

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Single dose PK exposure parameters: Maximum concentration (Cmax)

    Measured: From predose through 672 hours post-dose (multiple time points)

  2. 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)

    Measured: From predose through 672 hours post-dose (multiple time points)

  3. Single dose PK exposure parameters: AUC from time zero extrapolated to infinite time (AUC0-i)

    Measured: From predose through 672 hours post-dose (multiple time points)

Secondary outcomes (1)

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

    Measured: Week 5

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Feb 2026
  2. Study start25 Feb 2026
  3. Primary completionSep 2026 (estimated)
  4. Study completion27 Sep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07385547
Sponsor's protocol ID
UTRE-25-01
Status last verified
Mar 2026
First submitted
27 Jan 2026
Last updated
13 Mar 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GL0034 in people with Type II Diabetes Mellitus, run by Sun Pharmaceutical Industries Limited at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Head Regulatory Affairs (9122 66455645 ext. 5789, Clinical.Trial@sunpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Single dose PK exposure parameters: Maximum concentration (Cmax) (time frame: From predose through 672 hours post-dose (multiple time points)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07385547.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.

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