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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-524921-42-00 | EU Trial (CTIS) Number |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 | Other | Participants will be randomized to investigational drug or placebo |
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| Part 2 | Other | Participants will be randomized to investigational drug or placebo |
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| Part 3 | Other | GUB-UCN2 will be investigated as monotherapy and on top of standard of care obesity treatment against placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GUB-UCN2 | Drug | GUB-UCN2 will be administered subcutaneously |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Treatment Emergent Adverse Events | From baseline up to week 22 |
| Measure | Description | Time Frame |
|---|---|---|
| AUC(0-â),SD | Area under the GUB-UCN2 time-concentration curve from zero to infinity | From baseline up to week 6 |
| AUC(0-last),SD | Area under the GUB-UCN2 time-concentration curve from zero to last quantifiable observation |
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Inclusion Criteria:
Part 1
Part 2
Part 3 (participants with obesity)
Part 3 (participants with T2D)
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sr. Clinical Trial Manager | Contact | +45 3152 2650 | drugdevelopment@gubra.dk |
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Parts 1 and 2: Single Group assignment. Part 3: Parallel assignment
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| Placebo | Drug | Placebo will be administered subcutaneously |
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| From baseline up to week 6 |
| tmax,SD | Time to maximum observed GUB-UCN2 concentration up to the last sample collection | From baseline up to week 6 |
| Cmax,SD | Maximum observed GUB-UCN2 concentration after single dose | From baseline up to week 6 |
| AUCĪ,SS | Area under the GUB-UCN2 concentration time-curve | From baseline up to week 22 |
| Cmax, SS | Maximum observed GUB-UCN2 concentration | From baseline up to week 22 |
| tmax, SS | Time to maximum observed GUB-UCN2 concentration | From baseline up to week 22 |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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