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This is a Phase 2 randomized, double-blind, placebo-controlled, parallel arm study of NA-931 in adults who are obese (BMI ≥30 kg/m2) or who are overweight (BMI ≥27 kg/m2) with at least one weight-related co-morbid condition.
This is a Phase 2, 13-week randomized, double-blind, placebo-controlled, parallel arm study that will evaluate the safety, tolerability, weight loss efficacy, pharmacodynamic effects, and pharmacokinetics of NA-931 in adults who are obese (BMI ≥30 kg/m2) or who are overweight (BMI ≥27 kg/m2) with at least one weight-related co-morbid condition.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Comparator: NA-931(Placebo) | Placebo Comparator | Placebo Comparator: NA-931(Placebo) Placebo |
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| Experimental: NA-931 - daily orally (Dose #1) | Experimental | Experimental: NA-931 - daily orally (Dose #1) NA-931 is a peptide quadruple receptor agonist of Insulin-like Growth Hormone 1 (IGF-1), Glucagon-Like Peptide 1 (GLP-1), Glucose-dependent Insulinotropic Polypeptide (GIP), Glucagon Receptor |
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| Experimental: NA-931 - daily orally (Dose #2) | Experimental | Experimental: NA-931 - daily orally (Dose #2) NA-931 is a peptide quadruple receptor agonist of Insulin-like Growth Hormone 1 (IGF-1), Glucagon-Like Peptide 1 (GLP-1), Glucose-dependent Insulinotropic Polypeptide (GIP), Glucagon Receptor |
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| Experimental: NA-931 - daily orally (Dose #3) | Experimental | Experimental: NA-931 - daily orally (Dose #3) NA-931 is a peptide quadruple receptor agonist of Insulin-like Growth Hormone 1 (IGF-1), Glucagon-Like Peptide 1 (GLP-1), Glucose-dependent Insulinotropic Polypeptide (GIP), Glucagon Receptor |
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| Experimental: NA-931 - daily orally (Dose #4) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drug: Placebo daily and orally | Drug | • Placebo comparator |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent (relative) change from baseline to Week 13 in body weight | To measure the efficacy of NA-931 for weight loss in adult subjects who are obese, or overweight with at least one weight-related comorbid condition | 13 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects losing ≥5% and ≥10% of baseline weight at Week 13 | To measure the efficacy of NA-931 for weight loss in adult subjects who are obese, or overweight with at least one weight-related comorbid condition | 13 weeks |
| Incidence of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse event (TESAEs), adverse events of special interest (AESI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lloyd Tran, PhD | Biomed Industries, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biomed Investigational Site | Camperdown | New South Wales | 2050 | Australia | ||
| Biomed Investigational Site |
The investigators plan to share individual participant data (IPD) available to other researchers.
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randomized, double-blind, placebo-controlled, parallel arm study
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Experimental: NA-931 - daily orally (Dose #4) NA-931 is a peptide quadruple receptor agonist of Insulin-like Growth Hormone 1 (IGF-1), Glucagon-Like Peptide 1 (GLP-1), Glucose-dependent Insulinotropic Polypeptide (GIP), Glucagon Receptor |
|
| NA-931, dose 1, daily and orally | Drug | Drug: NA-931 dose 1, daily and orally • NA-931 is a peptide quadruple GLP-1, IGF-1, GIP , Glucagon quadruple agonist |
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| NA-931, dose2, daily and orally | Drug | Drug: NA-931 dose 2, daily and orally • NA-931 is a peptide quadruple GLP-1, IGF-1, GIP , Glucagon quadruple agonist |
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| NA-931 dose 3, daily and orally | Drug | Drug: NA-931 dose 3, daily and orally • NA-931 is a peptide quadruple GLP-1, IGF-1, GIP , Glucagon quadruple agonist |
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| NA-931 dose 4, daily and orally | Drug | Drug: NA-931 dose 4, daily and orally • NA-931 is a peptide quadruple GLP-1, IGF-1, GIP , Glucagon quadruple agonist |
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To evaluate the safety and tolerability including treatment-emergent adverse events (TEAEs), TESAEs, AESI of NA-931 for weight loss in adult subjects who are obese, or overweight with at least one weight-related comorbid condition |
| 13 weeks |
| Merewether |
| New South Wales |
| 2291 |
| Australia |
| Biomed Investigational Site | St Leonards | New South Wales | 2065 | Australia |
| Biomed Investigational Site | Heidelberg Heights | Victoria | 3081 | Australia |
| Biomed Investigational Site | Melbourne | Victoria | 3004 | Australia |
| ID | Term |
|---|---|
| D015431 | Weight Loss |
| D009765 | Obesity |
| D001835 | Body Weight |
| D001836 | Body Weight Changes |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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