Obesity, Type 2 Diabetes
Conditions
Brief summary
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
Interventions
DRUGGUB-UCN2
GUB-UCN2 will be administered subcutaneously
DRUGPlacebo
Placebo will be administered subcutaneously
Sponsors
Gubra A/S
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Parts 1 and 2: Single Group assignment. Part 3: Parallel assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Treatment Emergent Adverse Events | From baseline up to week 22 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUC(0-∞),SD | From baseline up to week 6 | Area under the GUB-UCN2 time-concentration curve from zero to infinity |
| AUC(0-last),SD | From baseline up to week 6 | Area under the GUB-UCN2 time-concentration curve from zero to last quantifiable observation |
| tmax,SD | From baseline up to week 6 | Time to maximum observed GUB-UCN2 concentration up to the last sample collection |
| Cmax,SD | From baseline up to week 6 | Maximum observed GUB-UCN2 concentration after single dose |
| AUCτ,SS | From baseline up to week 22 | Area under the GUB-UCN2 concentration time-curve |
| Cmax, SS | From baseline up to week 22 | Maximum observed GUB-UCN2 concentration |
| tmax, SS | From baseline up to week 22 | Time to maximum observed GUB-UCN2 concentration |
Countries
Germany
Contacts
CONTACTSr. Clinical Trial Manager
Outcome results
None listed