- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06732245
Safety and Efficacy of NA-931 and Tirzepatide in Adults Who Are Overweight or Obese
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Lloyd Tran, PhD
- Phone Number: 1-800-824-5135
- Email: research@biomedind.com
Study Contact Backup
- Name: Jennifer Thompson, MS
- Phone Number: 1-800-824-5135
- Email: research@biomedind.com
Study Locations
-
-
New South Wales
-
Brookvale, New South Wales, Australia, 2100
- Biomed Research Unit-NSW-2100-109
-
Contact:
- David Nguyen, PhD
- Phone Number: 1-800-824-5135
- Email: research@biomedind.com
-
Contact:
- Jennifer Thompson, MS
- Phone Number: 1-800-824-5135
- Email: research@biomedind.com
-
Principal Investigator:
- David Nguyen, PhD
-
Saint Leonards,, New South Wales, Australia, 2065
- Biomed Research Unit-NSW-2065-110
-
Contact:
- David Nguyen, PhD
- Phone Number: 1-800-824-5135
- Email: research@biomedind.com
-
Principal Investigator:
- David Nguyen, PhD
-
Contact:
- Jennifer Thompson
- Phone Number: 1-800-824-5235
- Email: esearch@biomedind.com
-
-
Queensland
-
South Brisbane, Queensland, Australia, 4101
- , Australia, 4101 Biomed Research Unit-NSW-4101-111
-
Contact:
- David Nguyen, PhD
- Phone Number: 1-800-824-5135
- Email: research@biomedind.com
-
Contact:
- Jennifer Thompson, MS
- Phone Number: 1-800-824-5135
- Email: research@biomedind.com
-
Principal Investigator:
- David Nguyen, PhD
-
-
Victoria
-
Camberwell, Victoria, Australia, 3124
- Biomed Research Unit-VIC-3124-112
-
Contact:
- David Nguyen, PhD
- Phone Number: 1-800-824-5135
- Email: research@biomedind.com
-
Principal Investigator:
- David Nguyen, PhD
-
Contact:
- Jennifer Thompson, MS
- Phone Number: 1-800-824-5135
- Email: esearch@biomedind.com
-
Heidelberg West, Victoria, Australia, 3084
- , Victoria, Australia, 3084 Biomed Research Unit-VIC-3084-113
-
Contact:
- David Nguyen, PhD
- Phone Number: 1-800-824-5135
- Email: research@biomedind.com
-
Contact:
- Jennifer Thompson, MS
- Phone Number: 1-800-824-5135
- Email: research@biomedind.com
-
Principal Investigator:
- David Nguyen, PhD
-
-
-
-
-
Auckland, New Zealand, 1010
- Biomed Research Unit-NZ-1010-114
-
Contact:
- David Nguyen, PhD
- Phone Number: 1-800-824-5135
- Email: research@biomedind.com
-
Contact:
- Jennifer Thompson, MS
- Phone Number: 1-800-824-5135
- Email: research@biomedind.com
-
Principal Investigator:
- David Nguyen, PhD
-
Hamilton, New Zealand, 3200
- Hamilton, New Zealand, 3200 Biomed Research Unit-NZ-3200-116
-
Contact:
- David Nguyen, PhD
- Phone Number: 1-800-824-5135
- Email: research@biomedind.com
-
Contact:
- Jennifer Thompson, MS
- Phone Number: 1-800-824-5135
- Email: research@biomedind.com
-
Principal Investigator:
- David Nguyen, PhD
-
-
Auckland
-
Papatoetoe, Auckland, New Zealand, 2025
- Biomed Research Unit-NZ-2025-115
-
Contact:
- David Nguyen, PhD
- Phone Number: 1-800-824-5135
- Email: research@biomedind.com
-
Contact:
- Jennifer Thompson, MS
- Phone Number: 1-800-824-5135
- Email: research@biomedind.com
-
Principal Investigator:
- David Nguyen, PhD
-
-
Wellington Region
-
Newtown, Wellington Region, New Zealand, 6242
- Biomed Research Unit-NZ- 6242-117
-
Contact:
- David Nguyen, PhD
- Phone Number: 1-824-5135
- Email: research@biomedind.com
-
Principal Investigator:
- David Nguyen, PhD
-
Contact:
- Jennifer Thompson
- Phone Number: 1-800-824-5135
- Email: research@biomedind.com
-
-
-
-
California
-
Los Angeles, California, United States, 90067
- Biomed Research Unit #90067-102
-
Contact:
- Jennifer Thompson, MS
- Phone Number: 1-800-824-5135
- Email: research@biomedind.com
-
Contact:
- David Nguyen, PhD
- Phone Number: 800-824-5135
- Email: research@biomedind.com
-
Principal Investigator:
- David Nguyen, PhD
-
San Diego, California, United States, 92121
- Biomed Research Unit # 92121-103
-
Contact:
- Jennifer Thompson, MS
- Phone Number: 1-800-824-5235
- Email: research@biomedind.com
-
Principal Investigator:
- David Nguyen, PhD
-
Contact:
- David Nguyen, PhD
- Phone Number: 800-824-5235
- Email: research@biomedind.com
-
San Francisco, California, United States, 94104
- Biomed Research Unit # 94104-101
-
Contact:
- Jennifer Thompson, MS
- Phone Number: 1-800-824-5135
- Email: research@biomedind.com
-
Contact:
- David Nguyen, PhD
- Phone Number: 800-824-5135
- Email: research@biomedind.com
-
Principal Investigator:
- David Nguyen, PhD
-
-
Florida
-
Hialeah, Florida, United States, 33012
- Biomed Research Unit # 33012-104
-
Principal Investigator:
- David Nguyen, PhD
-
Contact:
- David Nguyen, PhD
- Phone Number: 800-824-5235
- Email: research@biomedind.com
-
Contact:
- Jennifer Thompson, MS
-
Jacksonville, Florida, United States, 32256
- Biomed Research Unit # 32256-105
-
Contact:
- Jennifer Thompson, MS
- Phone Number: 1-800-824-5135
- Email: research@biomedind.com
-
Contact:
- David Nguyen, PhD
- Phone Number: 800-824-5135
- Email: research@biomedind.com
-
Principal Investigator:
- David Nguyen, PhD
-
Lake Worth, Florida, United States, 33461
- Biomed Research Unit # 33461-106
-
Contact:
- David Nguyen, PhD
- Phone Number: 800-824-5135
- Email: research@biomedind.com
-
Principal Investigator:
- David Nguyen, PhD
-
Contact:
- Jennifer Thompson, MS
- Phone Number: 1-800-824-5135
- Email: esearch@biomedind.com
-
-
New York
-
New York, New York, United States, 10021
- Biomed Research Unit # 10021-107
-
Contact:
- Jennifer Thompson, MS
- Phone Number: 1-800-824-5135
- Email: research@biomedind.com
-
Contact:
- David Nguyen, PhD
- Phone Number: 800-824-5135
- Email: research@biomedind.com
-
Principal Investigator:
- David Nguyen, PhD
-
-
Texas
-
Sugar Land, Texas, United States, 77479
- Biomed Research Unit # 77479-108
-
Contact:
- Jennifer Thompson, MS
- Phone Number: 1-800-824-5135
- Email: research@biomedind.com
-
Contact:
- David Nguyen, PhD
- Phone Number: 800-824-5135
- Email: research@biomedind.com
-
Principal Investigator:
- David Nguyen, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 exclusion criteria, which in the Investigator's opinion, might jeopardize the participant's safety or compliance with the protocol
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Placebo Comparator: Placebo
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.
|
NA-931 (oral, daily), a quadruple receptor agonist Tirzepatide (Zepbound) placebo
Other Names:
NA-931, an oral, daily • A quadruple receptor agonist NA-931 (oral, daily), a quadruple receptor agonist Tirzepatide (s.c. weekly)
Other Names:
NA-931 (oral daily), a quadruple receptor agonist Tirzepatide (s.c. weekly)
Other Names:
|
|
Placebo Comparator: Placebo + Tirzepatide 5 mg
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.
|
NA-931 (oral, daily), a quadruple receptor agonist Tirzepatide (Zepbound) placebo
Other Names:
NA-931, an oral, daily • A quadruple receptor agonist NA-931 (oral, daily), a quadruple receptor agonist Tirzepatide (s.c. weekly)
Other Names:
NA-931 (oral daily), a quadruple receptor agonist Tirzepatide (s.c. weekly)
Other Names:
|
|
Placebo Comparator: Placebo + Tirzepatide 10 mg
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.
|
Tirzepatide (s.c. weekly)
Other Names:
Tirzepatide (s.c. weekly), a Glucagon-like peptide-1 (GLP-1) receptor agonist • Other Names:
NA-931 Placebo (oral, daily)
Other Names:
NA-931 150 mg + no Tirzepatide
|
|
Experimental: NA-931 60mg to 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.
|
NA-931 (oral, daily), a quadruple receptor agonist Tirzepatide (Zepbound) placebo
Other Names:
NA-931, an oral, daily • A quadruple receptor agonist NA-931 (oral, daily), a quadruple receptor agonist Tirzepatide (s.c. weekly)
Other Names:
NA-931 (oral daily), a quadruple receptor agonist Tirzepatide (s.c. weekly)
Other Names:
|
|
Active Comparator: NA-931 60 mg + Tirzepatide 5 mg
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.
|
NA-931 (oral, daily), a quadruple receptor agonist Tirzepatide (Zepbound) placebo
Other Names:
NA-931, an oral, daily • A quadruple receptor agonist NA-931 (oral, daily), a quadruple receptor agonist Tirzepatide (s.c. weekly)
Other Names:
NA-931 (oral daily), a quadruple receptor agonist Tirzepatide (s.c. weekly)
Other Names:
|
|
Active Comparator: NA-931 120 mg + Tirzepatide 5 mg
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.
|
NA-931 (oral, daily), a quadruple receptor agonist Tirzepatide (Zepbound) placebo
Other Names:
NA-931, an oral, daily • A quadruple receptor agonist NA-931 (oral, daily), a quadruple receptor agonist Tirzepatide (s.c. weekly)
Other Names:
NA-931 (oral daily), a quadruple receptor agonist Tirzepatide (s.c. weekly)
Other Names:
|
|
Experimental: NA-931 150 mg + no Tirzepatide
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
|
Tirzepatide (s.c. weekly)
Other Names:
Tirzepatide (s.c. weekly), a Glucagon-like peptide-1 (GLP-1) receptor agonist • Other Names:
NA-931 Placebo (oral, daily)
Other Names:
NA-931 150 mg + no Tirzepatide
|
|
Active Comparator: NA-931 150 mg + Tirzepatide 2.5 mg
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.
|
NA-931 (oral, daily), a quadruple receptor agonist Tirzepatide (Zepbound) placebo
Other Names:
NA-931, an oral, daily • A quadruple receptor agonist NA-931 (oral, daily), a quadruple receptor agonist Tirzepatide (s.c. weekly)
Other Names:
NA-931 (oral daily), a quadruple receptor agonist Tirzepatide (s.c. weekly)
Other Names:
Tirzepatide (s.c. weekly)
Other Names:
Tirzepatide (s.c. weekly), a Glucagon-like peptide-1 (GLP-1) receptor agonist • Other Names:
NA-931 Placebo (oral, daily)
Other Names:
|
|
Active Comparator: NA-931 150 mg + Tirzepatide 5 mg
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.
|
NA-931 (oral, daily), a quadruple receptor agonist Tirzepatide (Zepbound) placebo
Other Names:
NA-931, an oral, daily • A quadruple receptor agonist NA-931 (oral, daily), a quadruple receptor agonist Tirzepatide (s.c. weekly)
Other Names:
NA-931 (oral daily), a quadruple receptor agonist Tirzepatide (s.c. weekly)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
48 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline in waist circumference (cm) at 48 weeks
Time Frame: 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)
Time Frame: 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.
|
48 weeks
|
|
Change from baseline at 48 weeks in percent body fat
Time Frame: 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.
|
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
|
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
Time Frame: 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
|
|
Proportion of participants at 48 weeks with change in Body weight ≥ 5%, ≥ 10% and ≥15%
Time Frame: 48 weeks
|
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)
Time Frame: 48 weeks
|
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)
Time Frame: 48 weeks
|
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)
Time Frame: 48 weeks
|
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)
Time Frame: 48 weeks
|
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)
Time Frame: 48 weeks
|
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)
Time Frame: 48 weeks
|
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]
Time Frame: 48 weeks
|
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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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).
|
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
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Lloyd Tran, PhD, Biomed Industries, Inc.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nutrition Disorders
- Overnutrition
- Body Weight
- Pathological Conditions, Signs and Symptoms
- Nutritional and Metabolic Diseases
- Signs and Symptoms
- Overweight
- Obesity
- Amino Acids, Peptides, and Proteins
- Proteins
- Glucagon-Like Peptide-1 Receptor
- Glucagon-Like Peptide Receptors
- Receptors, G-Protein-Coupled
- Receptors, Cell Surface
- Membrane Proteins
- Receptors, Gastrointestinal Hormone
- Receptors, Peptide
- Tirzepatide
Other Study ID Numbers
- NA-931-200
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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