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A randomized, double-blind, placebo-controlled, dose escalation, first in human study designed to assess the safety and tolerability, pharmacokinetics, and pharmacodynamics of NA-931 when administered as single and multiple-ascending doses in overweight/obese participants and as multiple doses in patients with T2DM.
A randomized, double-blind, placebo-controlled, dose escalation, first in human study designed to assess the safety and tolerability, pharmacokinetics, and pharmacodynamics of NA-931 when administered as single and multiple-ascending doses in overweight/obese participants and as multiple doses in patients with Type 2 Diabetes Mellitus.
NA-931 is a Quadruple Receptor Agonist for Insulin Like Growth Factor 1 (IGF-1), Glucagon-like Peptide-1 (GLP-1), Gastric Inhibitory Polypeptide (GIP) and Glucagon.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participant Group/Arm- NA-931 | Experimental | Experimental: NA-931 Capsule of NA-931 intervention |
|
| Participant Group/Arm- Placebo | Placebo Comparator | Placebo Comparator: Placebo Capsule of placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NA-931 | Drug | NA-931 is a quadruple receptor agonist for weight loss |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events in NA-931 participants | To evaluate the safety and tolerability of NA-931 | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observe drug concentration (Cmax) of NA-931 | Pharmacokinetics (PK) Cmax | 28 days |
| Effect of a High-Fat Meal on Plasma Concentration of NA-931 | Determine the effect of a high-fat meal on the Pharmacokinetics of NA-931following a single dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lloyd Tran, PhD | Biomed Industries, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biomed Industries Pty Limited- Clinical Testing Site 1 | Camperdown | New South Wales | 2050 | Australia | ||
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| Placebo | Drug | Placebo of NA-931 |
|
|
| 28 days |
| Biomed Industries, Pty Limited Testing Site 2 |
| Parkville |
| Victoria |
| 3052 |
| Australia |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| 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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