Phase
Condition
Obesity
Diabetes Mellitus, Type 2
Diabetes Prevention
Treatment
NNC0487-0111
Clinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or female, aged 18-80 years (both inclusive) at the time of signing theinformed consent
Body mass index (BMI) between 20.0 and 39.9 kilogram per square meter (kg/m^2) (bothinclusive) at screening.
Meeting the pre-defined eGFR values based on the Chronic Kidney Disease EpidemiologyCollaboration (CKD-EPI) creatinine equation (2021) adjusted for the estimatedindividual body surface area (BSA);
Normal renal function - greater than or equal to 90 mL/min
Mild renal impairment - 60 - 89 (mL/min)
Moderate renal impairment - 30 - 59 (mL/min)
Severe renal impairment - less than 30 (mL/min) not requiring dialysis
End-stage renal disease (ESRD) - Requiring dialysis treatment
For ESRD: Participants requiring dialysis treatment should be on current treatmentwith haemodialysis.
Exclusion
Exclusion Criteria:
Any disorder, unwillingness, or inability which in the investigator's opinion mightjeopardize participant's safety or compliance with the protocol.
Use of drugs known to affect creatinine clearance including cephalosporin andaminoglycoside, antibiotics, flucytosine, cisplatin, cimetidine, trimethoprim,cibenzoline, and nitrofurantoin within 14 days or 5 half-lives, whichever isgreater, before dosing the investigational medicinal product (IMP).
Presence or history of any clinically relevant respiratory, metabolic, hepatic,cardiovascular, gastrointestinal, or endocrinological conditions(except conditionsassociated with renal impairment or ESRD).
Study Design
Connect with a study center
Charité Research Organisation GmbH
Berlin, 10117
GermanySite Not Available
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