๐ฌIn plain words
What the trial is, and whether it could suit you
The trial will enroll healthy volunteers and individuals living with obesity, with and without Type 2 Diabetes. The study, with a treatment period of up to 16 weeks in selected cohorts, will investigate GUB-UCN2 as both a standalone therapy and on top of standard of care for obesity
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria:
Part 1
* Signed and dated informed consent obtained before any trial-related activities
* Males and female participants, aged between 18-55 years
* Body Mass Index (BMI) between 20.0 and 29.9 kg/m\^2, inclusive
* Considered generally healthy upon completion of medical history and screening safety assessments
Part 2
* Signed and dated informed consent obtained before any trial-related activities
* Male participants, aged between 18-55 years
* Body Mass Index (BMI) between 30.0 and 35.0 kg/m\^2, inclusive
Part 3 (participants with obesity)
* Signed and dated informed consent obtained before any trial-related activities
* Males and female participants, aged between 18-75 years
* Body Mass Index (BMI) between 30.0 and 45.0 kg/m\^2
Part 3 (participants with T2D)
* Signed and dated informed consent obtained before any trial-related activities
* Male and female participants, aged between 18-75 years
* Body Mass Index (BMI) between 27.0 and 35.0 kg/m\^2
* Diagnosed with type 2 diabetes mellitus, HbA1c โค 69.0 mmol/mol (โค 8.5%)
* Stable daily dose of antidiabetic medication
Exclusion Criteria:
* Known history of serious adverse reactions or serious hypersensitivity to drug or formulation excipients
* Presence or history of clinically significant gastrointestinal, cardiovascular, renal, hepatic, dermatological, respiratory, neurological, psychiatric, malignant, metabolic, endocrinological, hematologic or venereal disorder
* Use or planned use of concomitant medication impacting the assessment of trial endpoints
* Clinically significant abnormal laboratory parameters
* Women of childbearing potential who are not using highly effective contraception