Obesity and Overweight
Conditions
Keywords
NA-931, Obesity, Biomed Industries, Inc, overweight, Tirzepatide, Zepbound
Brief summary
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
Detailed description
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.
Interventions
DRUGNA-931
NA-931 (oral, daily), a quadruple receptor agonist Tirzepatide (Zepbound) placebo
DRUGTirzepatide
Tirzepatide (s.c. weekly) * Glucagon-like peptide-1 (GLP-1) receptor agonist * Other Names: * Mounjaro * Zepbound NA-931 Placebo (oral, daily)
DRUGNA-931 150 mg + no Tirzepatide
NA-931 150 mg + no Tirzepatide
Sponsors
Biomed Industries, Inc.
Bioneurals Ltd
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
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
Intervention model description
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 The extension period is then followed by a 12-week post-treatment period, during which all study treatments will be withdrawn from all arms.
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No
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: * Two negative pregnancy tests (at screening and at randomization, prior to dosing) * Use of intrauterine device, from at least 3 months before the baseline visit through at least 4 months after the last dose of NA-931/placebo oral, and an additional contraceptive (barrier) method from screening through at least 4 months after the last dose of NA-931/placebo oral. * 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®) * Use of other investigational drugs at the time of enrollment or within 30 days or 5 half-lives of enrollment, whichever is longer, or longer if required by local regulations * Treatment with any medication for the indication of obesity within the past 30 days before screening * Diagnosis of diabetes requiring current use of any antidiabetic drug or HbA1c ≥ 6.5% Note: Metabolic syndrome is not an exclusion, even if managed with an anti-diabetic drug such as metformin or an SGLT2 inhibitor. A diagnosis of prediabetes or impaired glucose tolerance managed exclusively with non-pharmacologic approaches (e.g., diet and exercise) is not an exclusion. * Any chronic infections likely to interfere with study conduct or interpretation such as hepatitis B (HBV), hepatitis C (HCV), or human immunodeficiency virus (HIV). History of hepatitis A or hepatitis C successfully treated is not exclusionary. Active COVID-19 infection. * Donation or loss of 400 mL or more of blood within 8 weeks prior to initial dosing, or longer if required by local regulation, or plasma donation (\> 250 mL) within 14 days prior to the first dose * Any disorder, unwillingness, or inability not covered by any of the other
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in body weight at 48 weeks | 48 weeks | Change in total body weight will be measured from baseline to 48 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in waist circumference (cm) at 48 weeks | 48 weeks | Waist circumference will be measured in standing position with a non-stretchable measuring tape and to the nearest 0.1 centimeter (cm). |
| Change from baseline at 48 weeks in total body fat mass in kilograms (kg) | 48 weeks | 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. |
| Change from baseline at 48 weeks in percent body fat | 48 weeks | 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. |
| 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) | 48 weeks | Dual energy X-ray absorptiometry (DXA) will be used to assess changes in body composition. |
| Proportion of participants at 48 weeks with change in waist circumference ≥ 5 cm | 48 weeks | Waist circumference will be measured in standing position with a non-stretchable measuring tape and to the nearest 0.1 centimeter (cm). |
| Proportion of participants at 48 weeks with change in Body weight ≥ 5%, ≥ 10% and ≥15% | 48 weeks | Body weight will be measured in kilograms (kg) to the nearest 0.1 kg. |
| Proportion of participants at 48 weeks with change in Fat mass ≥ 5% ≥ 10% ≥ 15% by Dual energy X-ray absorptiometry (DXA) | 48 weeks | Dual energy X-ray absorptiometry (DXA) will be used to assess the changes in body composition. |
| 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) | 48 weeks | Dual energy X-ray absorptiometry (DXA) will be used to assess changes in body composition. |
| Percentage of weight loss due to fat mass or lean mass at 48 weeks by dual-energy x-ray absorptiometry (DXA) | 48 weeks | Dual energy X-ray absorptiometry (DXA) will be used to assess changes in body composition |
| Change from baseline at 48 weeks in fat mass (kg and %) by bioelectrical impedance analysis (BIA) | 48 weeks | Bioelectrical impedance analysis (BIA) is a widely used method for estimating body composition. |
| Change from baseline at 48 weeks in lean mass (kg and %) and appendicular lean mass by dual-energy x-ray absorptiometry (DXA) | 48 weeks | Dual-energy x-ray absorptiometry (DXA) will be used to assess changes in body composition. |
| Change from baseline at 48 weeks in lean mass (kg) by bioelectrical impedance analysis (BIA) | 48 weeks | Bioelectrical impedance analysis (BIA) is a widely used method for estimating body composition. |
| Safety and tolerability measurements throughout 48 weeks by TEAEs [safety labs, vital signs] | 48 weeks | Incidence and severity of treatment emergent adverse events (TEAEs) |
| Proportion of Participants with change from baseline in Body Mass Index (BMI) categories at 48 weeks | 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 |
| Proportion of Participants with change from baseline in waist-to-height ratio (WHtR ratio) categories at 48 weeks | 48 weeks | Waist-to-height ratio WHtR ratio categories: \<0.5; 0.5-0.59; ≥0.6. |
| Change from baseline in HbA1c (mmol/mol) at 48 weeks | 48 weeks | To assess treatment effects on glucose metabolism and HbA1c. |
| Change from baseline at 48 weeks in Quality of Life Short Form 36 (SF-36) survey | 48 weeks | 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). |
| Change from Baseline at 48 weeks in Impact of Weight on Quality of Life-Lite for Clinical Trials (IWQOL-Lite) | 48 weeks | 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). |
Countries
Australia, New Zealand, United States
Contacts
CONTACTLloyd Tran, PhD
CONTACTJennifer Thompson, MS
STUDY_CHAIRLloyd Tran, PhD
Biomed Industries, Inc.
Outcome results
None listed