A Phase 2 interventional study of NA-931 and Tirzepatide in Obesity and Overweight, sponsored by Biomed Industries, Inc.. Not yet recruiting at 17 sites in 3 countries. Open to participants aged 19 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-03-27.
Sponsored by Biomed Industries, Inc. · Phase 2, Interventional, and Treatment
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.
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's planned enrollment of 224 is above the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →Biomed Industries, Inc. is the lead sponsor of 9 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
Exclusion Criteria:
History of, or known hypersensitivity to, monoclonal antibody drugs or a contraindication to Tirzepatide (Zepbound® or Mounjaro®)
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.
Drug: NA-931
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.
Drug: NA-931
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.
Drug: Tirzepatide · Drug: NA-931 150 mg + no Tirzepatide
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.
Drug: NA-931
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.
Drug: NA-931
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.
Drug: NA-931
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
Drug: Tirzepatide · Drug: NA-931 150 mg + no Tirzepatide
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.
Drug: Tirzepatide · Drug: NA-931
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.
Drug: NA-931
NA-931 (oral, daily), a quadruple receptor agonist Tirzepatide (Zepbound) placebo
Also known as: Tirzepatide placebo
Tirzepatide (s.c. weekly) * Glucagon-like peptide-1 (GLP-1) receptor agonist * Other Names: * Mounjaro * Zepbound NA-931 Placebo (oral, daily)
Also known as: NA-931 Placebo
Tirzepatide (s.c. weekly), a Glucagon-like peptide-1 (GLP-1) receptor agonist • Other Names: * Mounjaro * Zepbound NA-931 Placebo (oral, daily)
Also known as: NA-931 Placebo
NA-931, an oral, daily • A quadruple receptor agonist
NA-931 (oral, daily), a quadruple receptor agonist Tirzepatide (s.c. weekly) * Glucagon-like peptide-1 (GLP-1) receptor agonist * Other Names: * Mounjaro * Zepbound
Also known as: Tirzepatide
NA-931 (oral daily), a quadruple receptor agonist Tirzepatide (s.c. weekly) * Glucagon-like peptide-1 (GLP-1) receptor agonist * Other Names: * Mounjaro * Zepbound
Also known as: Tirzepatide
NA-931 150 mg + no Tirzepatide
NA-931 (oral, daily), a quadruple receptor agonist Tirzepatide (s.c. weekly) * Glucagon-like peptide-1 (GLP-1) receptor agonist * Other Names: * Mounjaro * Zepbound
Also known as: Tirzepatide
NA-931 (oral, daily), a quadruple receptor agonist Tirzepatide (s.c. weekly) * Glucagon-like peptide-1 (GLP-1) receptor agonist * Other Names: * Mounjaro * Zepbound
Also known as: Tirzepatide
Change from baseline in body weight at 48 weeks
Change in total body weight will be measured from baseline to 48 weeks
Time frame: 48 weeks
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).
Time frame: 48 weeks
Change from baseline at 48 weeks in total body fat mass in kilograms (kg)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 48 weeks
Safety and tolerability measurements throughout 48 weeks by TEAEs [safety labs, vital signs]
Incidence and severity of treatment emergent adverse events (TEAEs)
Time frame: 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
Time frame: 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.
Time frame: 48 weeks
Change from baseline in HbA1c (mmol/mol) at 48 weeks
To assess treatment effects on glucose metabolism and HbA1c.
Time frame: 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).
Time frame: 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).
Time frame: 48 weeks
Plan to share: No
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Biomed Industries, Inc.