Obesity and OverweightPhase 2NCT06732245
Safety and Efficacy of NA-931 and Tirzepatide in Adults Who Are Overweight or Obese
A Phase 2 study testing NA-931, Tirzepatide and NA-931 150 mg + no Tirzepatide in people with Obesity and Overweight, run by Biomed Industries, Inc. at 17 sites in 3 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Obesity and Overweight
- What is being tested?
- NA-931, Tirzepatide and NA-931 150 mg + no Tirzepatide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 224 participants
- Where
- 17 sitesin 3 countries
- Study dates
- 15 Aug 2026to 15 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- • 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 exclusion criteria, which in the Investigator's opinion, might jeopardize the participant's safety or compliance with the protocol
Trial locations and contacts
17 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
17 sites in 3 countries
United States8 sites
Biomed Research Unit # 33012-104
Hialeah, Florida, 33012
David Nguyen, PhD, 800-824-5235, research@biomedind.com
Jennifer Thompson, MS
Biomed Research Unit # 32256-105
Jacksonville, Florida, 32256
David Nguyen, PhD, 800-824-5135, research@biomedind.com
Jennifer Thompson, MS, 1-800-824-5135, research@biomedind.com
Biomed Research Unit # 33461-106
Lake Worth, Florida, 33461
David Nguyen, PhD, 800-824-5135, research@biomedind.com
Jennifer Thompson, MS, 1-800-824-5135, esearch@biomedind.com
Biomed Research Unit #90067-102
Los Angeles, California, 90067
David Nguyen, PhD, 800-824-5135, research@biomedind.com
Jennifer Thompson, MS, 1-800-824-5135, research@biomedind.com
Biomed Research Unit # 10021-107
New York, New York, 10021
David Nguyen, PhD, 800-824-5135, research@biomedind.com
Jennifer Thompson, MS, 1-800-824-5135, research@biomedind.com
Biomed Research Unit # 92121-103
San Diego, California, 92121
David Nguyen, PhD, 800-824-5235, research@biomedind.com
Jennifer Thompson, MS, 1-800-824-5235, research@biomedind.com
Biomed Research Unit # 94104-101
San Francisco, California, 94104
David Nguyen, PhD, 800-824-5135, research@biomedind.com
Jennifer Thompson, MS, 1-800-824-5135, research@biomedind.com
Biomed Research Unit # 77479-108
Sugar Land, Texas, 77479
David Nguyen, PhD, 800-824-5135, research@biomedind.com
Jennifer Thompson, MS, 1-800-824-5135, research@biomedind.com
Australia5 sites
Biomed Research Unit-NSW-2100-109
Brookvale, New South Wales, 2100
David Nguyen, PhD, 1-800-824-5135, research@biomedind.com
Jennifer Thompson, MS, 1-800-824-5135, research@biomedind.com
Biomed Research Unit-VIC-3124-112
Camberwell, Victoria, 3124
David Nguyen, PhD, 1-800-824-5135, research@biomedind.com
Jennifer Thompson, MS, 1-800-824-5135, esearch@biomedind.com
, Victoria, Australia, 3084 Biomed Research Unit-VIC-3084-113
Heidelberg West, Victoria, 3084
David Nguyen, PhD, 1-800-824-5135, research@biomedind.com
Jennifer Thompson, MS, 1-800-824-5135, research@biomedind.com
Biomed Research Unit-NSW-2065-110
Saint Leonards,, New South Wales, 2065
David Nguyen, PhD, 1-800-824-5135, research@biomedind.com
Jennifer Thompson, 1-800-824-5235, esearch@biomedind.com
, Australia, 4101 Biomed Research Unit-NSW-4101-111
South Brisbane, Queensland, 4101
David Nguyen, PhD, 1-800-824-5135, research@biomedind.com
Jennifer Thompson, MS, 1-800-824-5135, research@biomedind.com
New Zealand4 sites
Biomed Research Unit-NZ-1010-114
Auckland, 1010
David Nguyen, PhD, 1-800-824-5135, research@biomedind.com
Jennifer Thompson, MS, 1-800-824-5135, research@biomedind.com
Hamilton, New Zealand, 3200 Biomed Research Unit-NZ-3200-116
Hamilton, 3200
David Nguyen, PhD, 1-800-824-5135, research@biomedind.com
Jennifer Thompson, MS, 1-800-824-5135, research@biomedind.com
Biomed Research Unit-NZ- 6242-117
Newtown, Wellington Region, 6242
David Nguyen, PhD, 1-824-5135, research@biomedind.com
Jennifer Thompson, 1-800-824-5135, research@biomedind.com
Biomed Research Unit-NZ-2025-115
Papatoetoe, Auckland, 2025
David Nguyen, PhD, 1-800-824-5135, research@biomedind.com
Jennifer Thompson, MS, 1-800-824-5135, research@biomedind.com
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Multi-Center Study of Oral NA-931, Alone or in Addition to Open Label Subcutaneous Tirzepatide , to Investigate the Efficacy and Safety in Overweight or Obese Men and Women
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
Read the 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.
- Conditions
- Obesity and Overweight
- Being tested
- NA-931, Tirzepatide, NA-931 150 mg + no Tirzepatide
- Keywords
- NA-931, Obesity, Biomed Industries, Inc, overweight, Tirzepatide, Zepbound
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NA-931Drug
Also called Tirzepatide placebo
NA-931 (oral, daily), a quadruple receptor agonist
Tirzepatide (Zepbound) placebo
TirzepatideDrug
Also called NA-931 Placebo
Tirzepatide (s.c. weekly)
- Glucagon-like peptide-1 (GLP-1) receptor agonist
- Other Names:
- Mounjaro
- Zepbound NA-931 Placebo (oral, daily)
TirzepatideDrug
Also called 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)
NA-931Drug
NA-931, an oral, daily
- A quadruple receptor agonist
NA-931Drug
Also called 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
NA-931Drug
Also called 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
NA-931 150 mg + no TirzepatideDrug
NA-931 150 mg + no Tirzepatide
NA-931Drug
Also called 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
NA-931Drug
Also called 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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: NA-931 |
| 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. Receives: Drug: NA-931 |
| 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. Receives: Drug: Tirzepatide; Drug: NA-931 150 mg + no Tirzepatide |
| 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. Receives: Drug: NA-931 |
| NA-931 60 mg + Tirzepatide 5 mg | 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. Receives: Drug: NA-931 |
| 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. Receives: Drug: NA-931 |
| 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 Receives: Drug: Tirzepatide; Drug: NA-931 150 mg + no Tirzepatide |
| 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. Receives: Drug: Tirzepatide; Drug: NA-931 |
| 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. Receives: Drug: NA-931 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in body weight at 48 weeks
Change in total body weight will be measured from baseline to 48 weeks
Measured: 48 weeks
Secondary outcomes (18)
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 48 weeks
Safety and tolerability measurements throughout 48 weeks by TEAEs [safety labs, vital signs]
Incidence and severity of treatment emergent adverse events (TEAEs)
Measured: 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
Measured: 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.
Measured: 48 weeks
Change from baseline in HbA1c (mmol/mol) at 48 weeks
To assess treatment effects on glucose metabolism and HbA1c.
Measured: 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).
Measured: 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).
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2024
- Study start15 Aug 2026 (estimated)
- Primary completion15 Aug 2027 (estimated)
- Study completion15 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity and OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 224 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biomed Industries, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bioneurals Ltd
- Responsible party
- Sponsor
- Investigators
- Lloyd Tran, PhD, Study chair, Biomed Industries, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06732245
- Sponsor's protocol ID
- NA-931-200
- Status last verified
- Dec 2025
- First submitted
- 9 Dec 2024
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Multi-Center Study of Oral NA-931, Alone or in Addition to Open Label Subcutaneous Tirzepatide , to Investigate the Efficacy and Safety in Overweight or Obese Men and Women
- ClinicalTrials.gov ID
- NCT06732245
- Acronym / sponsor ID
- NA-931-200
- Conditions
- Obesity and Overweight
- Keywords
- NA-931, Obesity, Biomed Industries, Inc, overweight, Tirzepatide, Zepbound
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 224 participants (estimated)
- Lead sponsor
- Biomed Industries, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Bioneurals Ltd
- Study start
- 15 Aug 2026 (estimated)
- Primary completion
- 15 Aug 2027 (estimated)
- Study completion
- 15 Dec 2027 (estimated)
- First posted
- 13 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 9
- 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.
| Arm | Type | Receives |
|---|---|---|
| Placebo Comparator: Placebo | Placebo comparator | Drug: NA-931Placebo 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. |
| Placebo + Tirzepatide 5 mg | Placebo comparator | Drug: NA-931Other: 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. |
| Placebo + Tirzepatide 10 mg | Placebo comparator | Drug: Tirzepatide, Drug: NA-931 150 mg + no TirzepatidePlacebo + 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. |
| NA-931 60mg to NA-931 150 mg + no Tirzepatide | Experimental | Drug: NA-931Experimental: 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. |
| NA-931 60 mg + Tirzepatide 5 mg | Active comparator | Drug: NA-931NA-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. |
| NA-931 120 mg + Tirzepatide 5 mg | Active comparator | Drug: NA-931NA-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. |
| NA-931 150 mg + no Tirzepatide | Experimental | Drug: Tirzepatide, Drug: NA-931 150 mg + no TirzepatideExperimental: 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 |
| NA-931 150 mg + Tirzepatide 2.5 mg | Active comparator | Drug: Tirzepatide, Drug: NA-931NA-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. |
| NA-931 150 mg + Tirzepatide 5 mg | Active comparator | Drug: NA-931NA-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. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- • History of, or known hypersensitivity to, monoclonal antibody drugs or a contraindication to Tirzepatide (Zepbound® or Mounjaro®)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NA-931Also: Tirzepatide placeboNA-931 (oral, daily), a quadruple receptor agonist Tirzepatide (Zepbound) placebo | Drug | NA-931 120 mg + Tirzepatide 5 mg |
| TirzepatideAlso: NA-931 PlaceboTirzepatide (s.c. weekly) * Glucagon-like peptide-1 (GLP-1) receptor agonist * Other Names: * Mounjaro * Zepbound NA-931 Placebo (oral, daily) | Drug | NA-931 150 mg + no Tirzepatide |
| TirzepatideAlso: NA-931 PlaceboTirzepatide (s.c. weekly), a Glucagon-like peptide-1 (GLP-1) receptor agonist • Other Names: * Mounjaro * Zepbound NA-931 Placebo (oral, daily) | Drug | NA-931 150 mg + Tirzepatide 2.5 mg, Placebo + Tirzepatide 10 mg |
| NA-931NA-931, an oral, daily • A quadruple receptor agonist | Drug | NA-931 150 mg + Tirzepatide 5 mg |
| NA-931Also: TirzepatideNA-931 (oral, daily), a quadruple receptor agonist Tirzepatide (s.c. weekly) * Glucagon-like peptide-1 (GLP-1) receptor agonist * Other Names: * Mounjaro * Zepbound | Drug | NA-931 60 mg + Tirzepatide 5 mg |
| NA-931Also: TirzepatideNA-931 (oral daily), a quadruple receptor agonist Tirzepatide (s.c. weekly) * Glucagon-like peptide-1 (GLP-1) receptor agonist * Other Names: * Mounjaro * Zepbound | Drug | NA-931 120 mg + Tirzepatide 5 mg, NA-931 60mg to NA-931 150 mg + no Tirzepatide |
| NA-931 150 mg + no TirzepatideNA-931 150 mg + no Tirzepatide | Drug | NA-931 150 mg + no Tirzepatide, Placebo + Tirzepatide 10 mg |
| NA-931Also: TirzepatideNA-931 (oral, daily), a quadruple receptor agonist Tirzepatide (s.c. weekly) * Glucagon-like peptide-1 (GLP-1) receptor agonist * Other Names: * Mounjaro * Zepbound | Drug | NA-931 150 mg + Tirzepatide 2.5 mg, Placebo + Tirzepatide 5 mg |
| NA-931Also: TirzepatideNA-931 (oral, daily), a quadruple receptor agonist Tirzepatide (s.c. weekly) * Glucagon-like peptide-1 (GLP-1) receptor agonist * Other Names: * Mounjaro * Zepbound | Drug | NA-931 150 mg + Tirzepatide 5 mg, Placebo Comparator: Placebo |
Primary outcome
Change from baseline in body weight at 48 weeks
Time frame: 48 weeks
Change in total body weight will be measured from baseline to 48 weeks
18 secondary outcomes
Change from baseline in waist circumference (cm) at 48 weeks
Time frame: 48 weeks
Change from baseline at 48 weeks in total body fat mass in kilograms (kg)
Time frame: 48 weeks
Change from baseline at 48 weeks in percent body fat
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)
Time frame: 48 weeks
Proportion of participants at 48 weeks with change in waist circumference ≥ 5 cm
Time frame: 48 weeks
Proportion of participants at 48 weeks with change in Body weight ≥ 5%, ≥ 10% and ≥15%
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)
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)
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)
Time frame: 48 weeks
Change from baseline at 48 weeks in fat mass (kg and %) by bioelectrical impedance analysis (BIA)
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)
Time frame: 48 weeks
Change from baseline at 48 weeks in lean mass (kg) by bioelectrical impedance analysis (BIA)
Time frame: 48 weeks
Safety and tolerability measurements throughout 48 weeks by TEAEs [safety labs, vital signs]
Time frame: 48 weeks
Proportion of Participants with change from baseline in Body Mass Index (BMI) categories at 48 weeks
Time frame: 48 weeks
Proportion of Participants with change from baseline in waist-to-height ratio (WHtR ratio) categories at 48 weeks
Time frame: 48 weeks
Change from baseline in HbA1c (mmol/mol) at 48 weeks
Time frame: 48 weeks
Change from baseline at 48 weeks in Quality of Life Short Form 36 (SF-36) survey
Time frame: 48 weeks
Change from Baseline at 48 weeks in Impact of Weight on Quality of Life-Lite for Clinical Trials (IWQOL-Lite)
Time frame: 48 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lloyd Tran, PhD study chair
Biomed Industries, Inc.
17 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NA-931, Tirzepatide and NA-931 150 mg + no Tirzepatide in people with Obesity and Overweight, run by Biomed Industries, Inc. at 17 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States, Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lloyd Tran, PhD (1-800-824-5135, research@biomedind.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in body weight at 48 weeks (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.