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New treatment option for Type II Diabetes Mellitus
Official title Study to Evaluate if Exposure to Drug is Impacted in Participants With Renal Insufficiency
ClinicalTrials.gov ID: NCT07385547
What this study is testing
What is GL0034?
GL0034 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for type ii diabetes mellitus.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80. Healthy volunteers may be eligible.
You may be able to join 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;
You likely can't join 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.
See the full eligibility criteria
Who can 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;
- 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...
- 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...
- 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...
What rules you out
- 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...
- 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...
- 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...
- Participant participated in another treatment 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...
The study team makes the final eligibility decision.
Where it's taking place
- Miami, Florida, United States
- Miami Lakes, Florida, United States
- Orlando, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Miami, Florida, United States; Miami Lakes, Florida, United States; Orlando, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.