A Three-part First-in-human Trial to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GUB-UCN2 in Healthy Lean and Obese Participants and Participants With T2D

A Three-part First-in-human, Single and Multiple Ascending and Repeated Dose Trial to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneous GUB-UCN2 in Healthy Lean and Obese Participants and in Participants With Type 2 Diabetes

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

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 ≤ 69.0 mmol/mol (≤ 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