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| Name | Class |
|---|---|
| Bioneurals Ltd | UNKNOWN |
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A phase 2 study to assess the efficacy of NA-931 alone or in addition to Tirzepatide to assess efficacy and safety in overweight or obese men and women
This Phase 2 study investigates if NA-931 in addition to Tirzepatide can demonstrate synergic effects by enhancing efficacy and reducing adverse events including preserve/increase muscle mass in the presence of weight and/or fat mass loss.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Comparator: Placebo | Placebo Comparator | Placebo Comparator: Placebo to oral NA-931 120 mg daily + no Tirzepatide Participants will receive oral placebo at baseline and at Weeks 4, 12, and 24, 36, and 48 during the core treatment period and will switch during the extension period to receive NA-931 60 mg daily at Weeks 60 and 72. |
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| Placebo + Tirzepatide 5 mg | Placebo Comparator | Other: Placebo + Tirzepatide 5 mg Participants will receive oral placebo at baseline and at Weeks 4, 12, and 24, 36, and 48, and s.c. Tirzepatide 5 mg weekly per the dose escalation schedule. |
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| Placebo + Tirzepatide 10 mg | Placebo Comparator | Placebo + Tirzepatide 10 mg Participants will receive oral placebo at baseline and at Weeks 4, 12, and 24, 36, and 48 and s.c. Tirzepatide 10 mg weekly per the dose escalation schedule. |
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| NA-931 60mg to NA-931 150 mg + no Tirzepatide | Experimental | Experimental: NA-931 60mg to NA-931 150 mg + no Tirzepatide Participants will receive oral NA-931 60 mg at baseline and at Weeks 4, 12, and 24, 36, and 48 during the core treatment period and will switch during the extension period to receive NA-931 60 mg at Weeks 60 and 72. |
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| NA-931 60 mg + Tirzepatide 5 mg |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NA-931 | Drug | NA-931 (oral, daily), a quadruple receptor agonist Tirzepatide (Zepbound) placebo |
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| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in body weight at 48 weeks | Change in total body weight will be measured from baseline to 48 weeks | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in waist circumference (cm) at 48 weeks | Waist circumference will be measured in standing position with a non-stretchable measuring tape and to the nearest 0.1 centimeter (cm). | 48 weeks |
| Change from baseline at 48 weeks in total body fat mass in kilograms (kg) |
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Inclusion Criteria:
A written informed consent must be obtained before any study-related assessments are performed.
Men and women between 18 and 80 years, inclusive; women of child-bearing potential (defined as those who are not post-menopausal or post-surgical sterilization) must meet both of the following criteria:
Body mass index (BMI) ≥ 30 or BMI ≥ 27 with one or more obesity-associated comorbidities (e.g., hypertension, insulin resistance, sleep apnea, or dyslipidemia)
Stable body weight (± 5 kg) within 90 days of screening, and body weight <150 kg
Have a history of at least one self-reported unsuccessful behavioral effort to lose body weight
Able to communicate well with the Investigator, comply with the study requirements and adhere to the diet and activity programs for the study duration
Exclusion Criteria:
• History of, or known hypersensitivity to, monoclonal antibody drugs or a contraindication to Tirzepatide (Zepbound® or Mounjaro®)
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lloyd Tran, PhD | Contact | 1-800-824-5135 | research@biomedind.com | |
| Jennifer Thompson, MS | Contact | 1-800-824-5135 | research@biomedind.com |
| Name | Affiliation | Role |
|---|---|---|
| Lloyd Tran, PhD | Biomed Industries, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biomed Research Unit #90067-102 | Los Angeles | California | 90067 | United States |
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The study is designed to have three periods. The 48-week core treatment period has 9 treatment arms, with combinations of 3 Tirzepatide doses (none, 2.5 mg and 5 mg and 10 mg injectable) and 3 NA-931 doses (0, 60 mg and 150 mg oral). The core treatment period is then followed by an open-label 12-week treatment extension period during which participants originally assigned to either placebo or NA-931 60 mg will switch to NA-931 150 mg. All other treatment assignments will remain the same. The extension period is then followed by a 12-week post-treatment period, during which all study treatments will be withdrawn from all arms.
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With regards to NA-931 and placebo-NA-931, the participants, Investigator and Sponsor will be blinded.
Due to Tirzepatide being pre-filled, packaged and labeled by manufacturer, it is not possible to blind Tirzepatide
| Active Comparator |
NA-931 60 mg + Tirzepatide 5 mg Participants will receive oral NA-931 60 mg at baseline and at Weeks 4, 12, and 24, 36, and 48 and s.c. Tirzepatide 5 mg weekly per the dose escalation schedule. |
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| NA-931 120 mg + Tirzepatide 5 mg | Active Comparator | NA-931 120 mg + Tirzepatide 5 mg Participants will receive oral NA-931 60 mg at baseline and at Weeks 4, 12, and 24, 36, and 48 and s.c. Tirzepatide 5 mg weekly per the dose escalation schedule. |
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| NA-931 150 mg + no Tirzepatide | Experimental | Experimental: NA-931 150 mg + no Tirzepatide Participants will receive oral NA-931 150 mg at baseline and at Weeks 4, 12, 24, 36 and 48 |
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| NA-931 150 mg + Tirzepatide 2.5 mg | Active Comparator | NA-931 150 mg + Tirzepatide 2.5 mg Participants will receive oral NA-931 150 mg at baseline, and at Weeks 4, 12, and 24, 36, and 48 and s.c. Tirzepatide 2.5 mg weekly per the dose escalation schedule. |
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| NA-931 150 mg + Tirzepatide 5 mg | Active Comparator | NA-931 150 mg + Tirzepatide 5 mg Participants will receive oral NA-931 150mg at baseline and at Weeks 4, 12, and 24, 36, and 48 and s.c. Tirzepatide 5 mg per the dose escalation schedule. |
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| Tirzepatide | Drug | Tirzepatide (s.c. weekly)
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| Tirzepatide | Drug | Tirzepatide (s.c. weekly), a Glucagon-like peptide-1 (GLP-1) receptor agonist • Other Names:
NA-931 Placebo (oral, daily) |
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| NA-931 | Drug | NA-931, an oral, daily • A quadruple receptor agonist |
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| NA-931 | Drug | NA-931 (oral, daily), a quadruple receptor agonist Tirzepatide (s.c. weekly)
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| NA-931 | Drug | NA-931 (oral daily), a quadruple receptor agonist Tirzepatide (s.c. weekly)
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| NA-931 150 mg + no Tirzepatide | Drug | NA-931 150 mg + no Tirzepatide |
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| NA-931 | Drug | NA-931 (oral, daily), a quadruple receptor agonist Tirzepatide (s.c. weekly)
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| NA-931 | Drug | NA-931 (oral, daily), a quadruple receptor agonist Tirzepatide (s.c. weekly)
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Fat mass will be obtained by dual-energy x-ray absorptiometry (DXA) Dual energy X-ray absorptiometry (DXA) will be used to assess changes in body composition. |
| 48 weeks |
| Change from baseline at 48 weeks in percent body fat | Percent body fat will be obtained by dual-energy x-ray absorptiometry (DXA) Dual energy X-ray absorptiometry (DXA) will be used to assess changes in body composition. | 48 weeks |
| Change from baseline at 48 weeks in visceral adipose tissue (VAT), subcutaneous adipose tissue (SAT) and trunk fat mass by dual-energy x-ray absorptiometry (DXA) | Dual energy X-ray absorptiometry (DXA) will be used to assess changes in body composition. | 48 weeks |
| Proportion of participants at 48 weeks with change in waist circumference ≥ 5 cm | Waist circumference will be measured in standing position with a non-stretchable measuring tape and to the nearest 0.1 centimeter (cm). | 48 weeks |
| Proportion of participants at 48 weeks with change in Body weight ≥ 5%, ≥ 10% and ≥15% | Body weight will be measured in kilograms (kg) to the nearest 0.1 kg. | 48 weeks |
| Proportion of participants at 48 weeks with change in Fat mass ≥ 5% ≥ 10% ≥ 15% by Dual energy X-ray absorptiometry (DXA) | Dual energy X-ray absorptiometry (DXA) will be used to assess the changes in body composition. | 48 weeks |
| Proportion of participants at 48 weeks with change in Fat mass ≥ 10% with <5% decrease (or and increase) in lean mass by Dual energy X-ray absorptiometry (DXA) | Dual energy X-ray absorptiometry (DXA) will be used to assess changes in body composition. | 48 weeks |
| Percentage of weight loss due to fat mass or lean mass at 48 weeks by dual-energy x-ray absorptiometry (DXA) | Dual energy X-ray absorptiometry (DXA) will be used to assess changes in body composition | 48 weeks |
| Change from baseline at 48 weeks in fat mass (kg and %) by bioelectrical impedance analysis (BIA) | Bioelectrical impedance analysis (BIA) is a widely used method for estimating body composition. | 48 weeks |
| Change from baseline at 48 weeks in lean mass (kg and %) and appendicular lean mass by dual-energy x-ray absorptiometry (DXA) | Dual-energy x-ray absorptiometry (DXA) will be used to assess changes in body composition. | 48 weeks |
| Change from baseline at 48 weeks in lean mass (kg) by bioelectrical impedance analysis (BIA) | Bioelectrical impedance analysis (BIA) is a widely used method for estimating body composition. | 48 weeks |
| Safety and tolerability measurements throughout 48 weeks by TEAEs [safety labs, vital signs] | Incidence and severity of treatment emergent adverse events (TEAEs) | 48 weeks |
| Proportion of Participants with change from baseline in Body Mass Index (BMI) categories at 48 weeks | BMI categories: (i) Healthy weight: 18.5 kg/m2 to 24.9 kg/m2 (ii) Overweight: 25 kg/m2 to 29.9 kg/m2 (iii) Obesity class 1: 30 kg/m2 to 34.9 kg/m2 (iv) Obesity class II: 35 kg/m2 to 39.9 kg/m2 (v) Obesity class III: ≥ 40 kg/m2 | 48 weeks |
| Proportion of Participants with change from baseline in waist-to-height ratio (WHtR ratio) categories at 48 weeks | Waist-to-height ratio WHtR ratio categories: <0.5; 0.5-0.59; ≥0.6. | 48 weeks |
| Change from baseline in HbA1c (mmol/mol) at 48 weeks | To assess treatment effects on glucose metabolism and HbA1c. | 48 weeks |
| Change from baseline at 48 weeks in Quality of Life Short Form 36 (SF-36) survey | Change from baseline at 48 weeks in Quality of Life Short Form 36 (SF-36) survey. To assess a subject's overall health related quality of life, as well as the physical functioning score. SF- 36 scores range from 0 (worst) to 100 (best). | 48 weeks |
| Change from Baseline at 48 weeks in Impact of Weight on Quality of Life-Lite for Clinical Trials (IWQOL-Lite) | Change from baseline in IWQOL-Lite CT. IWQOL-Lite CT is a 20-item modified survey instrument that is used to quantitatively assess an individual's perception of how their weight affects their day- to-day life, as well as the physical function score. Scores range from 0 (worst) to 100 (best). | 48 weeks |
| Biomed Research Unit # 92121-103 | San Diego | California | 92121 | United States |
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| Biomed Research Unit # 94104-101 | San Francisco | California | 94104 | United States |
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| Biomed Research Unit # 33012-104 | Hialeah | Florida | 33012 | United States |
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| Biomed Research Unit # 32256-105 | Jacksonville | Florida | 32256 | United States |
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| Biomed Research Unit # 33461-106 | Lake Worth | Florida | 33461 | United States |
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| Biomed Research Unit # 10021-107 | New York | New York | 10021 | United States |
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| Biomed Research Unit # 77479-108 | Sugar Land | Texas | 77479 | United States |
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| Biomed Research Unit-NSW-2100-109 | Brookvale | New South Wales | 2100 | Australia |
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| Biomed Research Unit-NSW-2065-110 | Saint Leonards, | New South Wales | 2065 | Australia |
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| , Australia, 4101 Biomed Research Unit-NSW-4101-111 | South Brisbane | Queensland | 4101 | Australia |
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| Biomed Research Unit-VIC-3124-112 | Camberwell | Victoria | 3124 | Australia |
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| , Victoria, Australia, 3084 Biomed Research Unit-VIC-3084-113 | Heidelberg West | Victoria | 3084 | Australia |
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| Biomed Research Unit-NZ-2025-115 | Papatoetoe | Auckland | 2025 | New Zealand |
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| Biomed Research Unit-NZ- 6242-117 | Newtown | Wellington Region | 6242 | New Zealand |
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| Biomed Research Unit-NZ-1010-114 | Auckland | 1010 | New Zealand |
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| Hamilton, New Zealand, 3200 Biomed Research Unit-NZ-3200-116 | Hamilton | 3200 | New Zealand |
|
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| 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 |
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| ID | Term |
|---|---|
| D000098860 | Tirzepatide |
| ID | Term |
|---|---|
| D000067757 | Glucagon-Like Peptide-1 Receptor |
| D000067756 | Glucagon-Like Peptide Receptors |
| D043562 | Receptors, G-Protein-Coupled |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011964 | Receptors, Gastrointestinal Hormone |
| D018000 | Receptors, Peptide |
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