Albuminuria Reduction Study With Survodutide Treatment in Kidney Disease

Prior treatment

• Cardiovascular event within 3 months prior to enrolment
• Treatment with GLP-1RA for \<12 weeks prior to screening
• Acute pancreatitis \<180 days prior to screening
• Participation in any clinical trial within 3 months prior to initial dosing.
• Donation or loss of ≧400 ml blood within 8 weeks prior to initial dosing.

Other illness

• Diagnosis of type 1 diabetes
• History of kidney or liver transplant
• Active malignancy
• Suggestive evidence of adrenal insufficiency
• History of chronic pancreatitis or idiopathic acute pancreatitisPersonal or family history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma
• Personal history of non-familial medullary thyroid carcinoma
• History of severe hypersensitivity or contraindications to any glucagon RA or GLP-1 RA
• Uncontrolled arterial hypertension (mean semi supine systolic blood pressure (SBP) ≥180 mmHg or diastolic blood pressure (DBP) ≥110 mmHg)
• Any medication, surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of medications including, but not limited to any of the following:
  • History of active inflammatory bowel disease within the 6 months;
  • Major gastrointestinal tract surgery as determined by the physician;
  • Pancreatitis within 6 months.
  • GI ulcers and/or bleeding within 6 months;
  • Evidence of urinary obstruction or difficulty in voiding at screening.
• History of noncompliance to medical regimens or unwillingness to comply with the study protocol.
• Any surgical or medical condition, which in the opinion of the investigator, may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study.

Lab values

• Evidence of severe hepatic impairment determined by any one of: ALT or AST values exceeding 3x ULN, a history of hepatic encephalopathy, a history of oesophageal varices, or a history of portocaval shunt;
• History of drug or alcohol abuse within the 12 months prior to dosing, or evidence of such abuse as indicated by the laboratory assays conducted during the screening or according to investigator's assessment.
• Women of childbearing potential (WOCBP):
  • WOCBP who are unwilling or unable to use an acceptable method of contraception to avoid pregnancy throughout the study and for up to 8 weeks after the last dose of study drug in such a manner the risk of pregnancy is minimized.
  • WOCBP must have a negative serum or urine pregnancy test result (minimum sensitivity 25 IU/L or equivalent of HCG) at screening.

Other

• Active pregnancy or breastfeeding
• Calcitonin levels ≥100 pg/mL or 29.26 pmol/L
• Vulnerable (i.e. under guardianship) or mentally incapacitated subjects (i.e. not able to understand and sign the informed consent)

• Age ≥ 18 years
• eGFR ≥20 and \<90 mL/min/1.73m2
• Urinary albumin to creatinine ratio \>30 mg/g and \<3500 mg/g
• BMI \>21 kg/m2
• Stable kidney function (no more than 30% change in eGFR in the 3 months prior to enrolment)
• On a stable maximum tolerated dose of an ACEi/ARB for at least 4 weeks prior to enrolment
• If using an SGLT2 inhibitor, receiving a stable dose for at least 8 weeks prior to enrolment
• Willing to sign an informed consent