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This is a two-part study, intended to investigate the safety, tolerability, characteristics of PK and PD of single SC dose of SRSD384 alone in overweight or obese participants (Part A) and in combination with tirzepatide in overweight or obese participants with T2DM (Part B).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SRSD384 injection (Part A) | Experimental |
| |
| 0.9% Sodium Chloride (Part A) | Placebo Comparator |
| |
| SRSD384 injection (Part B) | Experimental |
| |
| 0.9% Sodium Chloride (Part B) | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SRSD384 injection | Drug | Administered S.C. per the protocol |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-emergent adverse events (TEAEs) | 168 days |
| Measure | Description | Time Frame |
|---|---|---|
| Maximal concentration of SRSD384 | 48 hours | |
| Area under the concentration-time curve from time 0 to infinity of SRSD384 | 48 hours | |
| Time to the maximal concentration of SRSD384 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Contact | +86 21 61207756 | medical@siriusrna.com | |
| Medical Director | Contact |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NovaTrials | Charlestown | New South Wales | 2290 | Australia |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| Placebo | Drug | Administered S.C. per the protocol |
|
| 48 hours |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |