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Study of NA-931 and Tirzepatide for Overweight or Obesity

This study is looking at NA-931, an oral medication, and Tirzepatide (also known as Mounjaro or Zepbound), an injectable medication, for adults who are overweight or have obesity. Researchers want to see how safe and effective these treatments are, both alone and together. The study aims to find out if combining NA-931 and Tirzepatide can work better, potentially by helping with weight loss and possibly preserving or increasing muscle mass. You may be able to join if you are between 19 and 80 years old. The main goal is to measure changes in body weight after 48 weeks.

Study design
This is a Phase 2 interventional study planning to enroll 224 participants. It aims to assess the efficacy and safety of NA-931 alone or in addition to Tirzepatide.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint measures changes in body weight at 48 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06732245

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

Not Yet Recruiting
PHASE2Ages 19–80InterventionalTreatment
Biomed Industries, Inc.
~224 participants
Updated 2026-03-27 on ClinicalTrials.gov
What's tested:NA-931TirzepatideNA-931 150 mg + no Tirzepatide

At a glance

Recruiting sites
0 of 17 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from baseline in body weight at 48 weeks
Measured over 48 weeks

Conditions

Obesity and Overweight

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ObesityOverweight

Where it's being run

17 sites across 10 states
California3
Florida3
New South Wales2
Victoria2
New Zealand2
New York1
Texas1
Queensland1

Study leadership

  • Lloyd Tran, PhD · STUDY_CHAIR · Biomed Industries, Inc.

Who to contact

Lloyd Tran, PhD
[email protected]
1-800-824-5135
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

• 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

What this trial measures

  • Change from baseline in body weight at 48 weeks48 weeks

    Change in total body weight will be measured from baseline to 48 weeks