Safety and Efficacy of NA-931 and Tirzepatide in Adults Who Are Overweight or Obese

March 24, 2026 updated by: Biomed Industries, Inc.

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

Study Overview

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 Type

Interventional

Enrollment (Estimated)

224

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • New South Wales
      • Brookvale, New South Wales, Australia, 2100
        • Biomed Research Unit-NSW-2100-109
        • Contact:
        • Contact:
        • Principal Investigator:
          • David Nguyen, PhD
      • Saint Leonards,, New South Wales, Australia, 2065
        • Biomed Research Unit-NSW-2065-110
        • Contact:
        • Principal Investigator:
          • David Nguyen, PhD
        • Contact:
    • Queensland
      • South Brisbane, Queensland, Australia, 4101
        • , Australia, 4101 Biomed Research Unit-NSW-4101-111
        • Contact:
        • Contact:
        • Principal Investigator:
          • David Nguyen, PhD
    • Victoria
      • Camberwell, Victoria, Australia, 3124
        • Biomed Research Unit-VIC-3124-112
        • Contact:
        • Principal Investigator:
          • David Nguyen, PhD
        • Contact:
      • Heidelberg West, Victoria, Australia, 3084
        • , Victoria, Australia, 3084 Biomed Research Unit-VIC-3084-113
        • Contact:
        • Contact:
        • Principal Investigator:
          • David Nguyen, PhD
      • Auckland, New Zealand, 1010
        • Biomed Research Unit-NZ-1010-114
        • Contact:
        • Contact:
        • Principal Investigator:
          • David Nguyen, PhD
      • Hamilton, New Zealand, 3200
        • Hamilton, New Zealand, 3200 Biomed Research Unit-NZ-3200-116
        • Contact:
        • Contact:
        • Principal Investigator:
          • David Nguyen, PhD
    • Auckland
      • Papatoetoe, Auckland, New Zealand, 2025
        • Biomed Research Unit-NZ-2025-115
        • Contact:
        • Contact:
        • Principal Investigator:
          • David Nguyen, PhD
    • Wellington Region
      • Newtown, Wellington Region, New Zealand, 6242
        • Biomed Research Unit-NZ- 6242-117
        • Contact:
        • Principal Investigator:
          • David Nguyen, PhD
        • Contact:
    • California
      • Los Angeles, California, United States, 90067
        • Biomed Research Unit #90067-102
        • Contact:
        • Contact:
        • Principal Investigator:
          • David Nguyen, PhD
      • San Diego, California, United States, 92121
        • Biomed Research Unit # 92121-103
        • Contact:
        • Principal Investigator:
          • David Nguyen, PhD
        • Contact:
      • San Francisco, California, United States, 94104
        • Biomed Research Unit # 94104-101
        • Contact:
        • Contact:
        • Principal Investigator:
          • David Nguyen, PhD
    • Florida
      • Hialeah, Florida, United States, 33012
        • Biomed Research Unit # 33012-104
        • Principal Investigator:
          • David Nguyen, PhD
        • Contact:
        • Contact:
          • Jennifer Thompson, MS
      • Jacksonville, Florida, United States, 32256
        • Biomed Research Unit # 32256-105
        • Contact:
        • Contact:
        • Principal Investigator:
          • David Nguyen, PhD
      • Lake Worth, Florida, United States, 33461
        • Biomed Research Unit # 33461-106
        • Contact:
        • Principal Investigator:
          • David Nguyen, PhD
        • Contact:
    • New York
      • New York, New York, United States, 10021
        • Biomed Research Unit # 10021-107
        • Contact:
        • Contact:
        • Principal Investigator:
          • David Nguyen, PhD
    • Texas
      • Sugar Land, Texas, United States, 77479
        • Biomed Research Unit # 77479-108
        • Contact:
        • Contact:
        • Principal Investigator:
          • David Nguyen, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • Tirzepatide 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
Other Names:
  • 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
Other Names:
  • Tirzepatide
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:
  • Tirzepatide 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
Other Names:
  • 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
Other Names:
  • Tirzepatide
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)

  • Glucagon-like peptide-1 (GLP-1) receptor agonist
  • Other Names:

    • Mounjaro
    • Zepbound NA-931 Placebo (oral, daily)
Other Names:
  • 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)

Other Names:
  • NA-931 Placebo
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:
  • Tirzepatide 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
Other Names:
  • 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
Other Names:
  • Tirzepatide
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:
  • Tirzepatide 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
Other Names:
  • 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
Other Names:
  • Tirzepatide
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:
  • Tirzepatide 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
Other Names:
  • 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
Other Names:
  • Tirzepatide
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)

  • Glucagon-like peptide-1 (GLP-1) receptor agonist
  • Other Names:

    • Mounjaro
    • Zepbound NA-931 Placebo (oral, daily)
Other Names:
  • 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)

Other Names:
  • NA-931 Placebo
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:
  • Tirzepatide 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
Other Names:
  • 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
Other Names:
  • Tirzepatide

Tirzepatide (s.c. weekly)

  • Glucagon-like peptide-1 (GLP-1) receptor agonist
  • Other Names:

    • Mounjaro
    • Zepbound NA-931 Placebo (oral, daily)
Other Names:
  • 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)

Other Names:
  • NA-931 Placebo
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:
  • Tirzepatide 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
Other Names:
  • 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
Other Names:
  • Tirzepatide

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

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Study Chair: Lloyd Tran, PhD, Biomed Industries, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 15, 2026

Primary Completion (Estimated)

August 15, 2027

Study Completion (Estimated)

December 15, 2027

Study Registration Dates

First Submitted

December 9, 2024

First Submitted That Met QC Criteria

December 9, 2024

First Posted (Actual)

December 13, 2024

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 24, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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