How kidney problems affect the body's handling of GL0034, a diabetes drug

Who can take part

• 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); 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 take part

• Participant is on continuous renal replacement therapy or peritoneal dialysis
• Participant is taking medications with a narrow therapeutic index such as digoxin, warfarin, etc
• 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 history of alcohol or drug abuse in the previous two years
• 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 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 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 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 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 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)
• 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 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 screening calcitonin ≥ 50 ng/L (pg/mL)
• Participant has a clinically significant ECG abnormality as judged by the Investigator
• 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