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New diabetes drug studied in kidney patients

NCT ID NCT07385547

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage study tests how a single dose of the diabetes drug GL0034 behaves in people with different levels of kidney function. About 40 adults with type 2 diabetes will be grouped by kidney health, from normal to severe impairment. Researchers will measure drug levels in the blood and check for side effects to guide future dosing.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
GL0034 (a long-acting GLP-1 receptor agonist)
What this could lead to
If successful, this study could help doctors decide safe dosing of GL0034 for people with type 2 diabetes who also have kidney problems.
What could go wrong
This is a very early Phase 1 study with only 40 people. It only looks at drug levels and safety after one dose, not long-term effects or effectiveness.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 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. 5. 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: 1. Confirmed infertility due to surgical procedure or post-menopausal (cessation of menses for at least 12 months prior to Screening). 2. Confirmed infertility of sexual partner or partner of the same sex. 3. Hormonal contraceptive (oral, combined, patch, vaginal ring, injectable, implant) in females. 4. Double-barrier method (any combination of physical and chemical methods). 5. Intrauterine device with a failure rate less than 1% per year. Male participants must: 6. 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. 7. Refrain from donating sperm during the trial and for at least 30 days after the end of the trial. 6. Participant is willing and able to comply with the study protocol, visit schedule, and other study-related instructions and procedures. Participants with Renal Impairment 7. 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. 8. 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. 9. 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). 10. 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. Exclusion Criteria: 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. 9. Participant has a known hypersensitivity to the study medications or excipients. 10. 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. 11. 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. 12. Participant had a myocardial infarction, unstable angina pectoris, or ischemic stroke within the past 6 months prior to investigational product administration. 13. Participant has a clinically significant ECG abnormality as judged by the Investigator. 14. 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. 15. Participant has a history of alcohol or drug abuse in the previous two years. 16. 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. 17. Participant has a known history of coagulopathy such that SC injection will result in excessive bleeding at the injection sites. 18. 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. 19. 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. 20. Participant has been placed in an institution on official or judicial orders. 21. Participant is related to or dependent on the Investigator, Sponsor, or study site such that a conflict of interest may arise. 22. 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).

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    3 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Orlando Clinical Research Center (OCRC)

    NOT_YET_RECRUITING

    Orlando, Florida, 32809, United States

  • Panax Clinical Research

    RECRUITING

    Miami Lakes, Florida, 33014, United States

  • Syneos Miami

    NOT_YET_RECRUITING

    Miami, Florida, 33136, United States

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