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

PHASE2NOT_YET_RECRUITING

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 details:

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.

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

  1. A written informed consent must be obtained before any study-related assessments are performed.
  2. 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:
  3. Two negative pregnancy tests (at screening and at randomization, prior to dosing)
  4. 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.
  5. Body mass index (BMI) ≥ 30 or BMI ≥ 27 with one or more obesity-associated comorbidities (e.g., hypertension, insulin resistance, sleep apnea, or dyslipidemia)
  6. Stable body weight (± 5 kg) within 90 days of screening, and body weight <150 kg
  7. Have a history of at least one self-reported unsuccessful behavioral effort to lose body weight
  8. 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

  1. History of, or known hypersensitivity to, monoclonal antibody drugs or a contraindication to Tirzepatide (Zepbound® or Mounjaro®)
  2. 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
  3. Treatment with any medication for the indication of obesity within the past 30 days before screening
  4. 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.
  5. 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.
  6. 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
  7. 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

Eligibility

Age eligible for study : NA

Healthy volunteers accepted : No

Gender eligible for study: ALL

Things to know

Study dates

Study start:

Primary completion:

Study completion finish:

study type

Study type

TREATMENT

phase

Phase

    PHASE2

trial

Study ID

NCT06732245

Intervention or treatment

DRUG: NA-931

DRUG: Tirzepatide

DRUG: Tirzepatide

DRUG: NA-931

DRUG: NA-931

DRUG: NA-931

DRUG: NA-931 150 mg + no Tirzepatide

DRUG: NA-931

DRUG: NA-931

Conditions

  • Obesity and Overweight

  • Condition: Obesity and Overweight

  • DRUG: NA-931 and other drugs

  • Brookvale, New South Wales, Australia and more

  • Sponsor: Biomed Industries, Inc.

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Are you running this trial?

If you're a clinic or sponsor, you can claim this study

Research sites nearby

Closest Location:

Biomed Research Unit-NSW-2100-109

Select from list below to view details:

  • Biomed Research Unit-NSW-2100-109

    Brookvale, New South Wales, Australia

  • Biomed Research Unit-NSW-2065-110

    Saint Leonards,, New South Wales, Australia

  • , Australia, 4101 Biomed Research Unit-NSW-4101-111

    South Brisbane, Queensland, Australia

  • Biomed Research Unit-VIC-3124-112

    Camberwell, Victoria, Australia

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Who is running the clinical trial?

BII

Biomed Industries, Inc.

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?

Participant Group/ArmIntervention/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.
Drug: NA-931
    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.
    Drug: NA-931
      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.
      Drug: Tirzepatide, Drug: 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.
        Drug: NA-931
          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.
          Drug: NA-931
            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.
            Drug: NA-931
              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
              Drug: Tirzepatide, Drug: 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.
                Drug: Tirzepatide, Drug: NA-931
                  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.
                  Drug: NA-931

                    What is the study measuring?

                    Primary Outcome

                    MeasureDescriptionTime Frame
                    Change from baseline in body weight at 48 weeksChange in total body weight will be measured from baseline to 48 weeks48 weeks

                    Secondary Outcome

                    MeasureDescriptionTime Frame
                    Change from baseline in waist circumference (cm) at 48 weeksWaist 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)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 fatPercent 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)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 cmWaist 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%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)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)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)Dual energy X-ray absorptiometry (DXA) will be used to assess changes in body composition48 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.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.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.48 weeks
                    Safety and tolerability measurements throughout 48 weeks by TEAEs [safety labs, vital signs]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 weeksBMI 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/m248 weeks
                    Proportion of Participants with change from baseline in waist-to-height ratio (WHtR ratio) categories at 48 weeksWaist-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 weeksTo 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) surveyChange 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)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
                    Are you running this trial?If you're a clinic or sponsor, you can claim this study.
                    Claim this trial

                    References

                    Clinical Trials Gov: Safety and Efficacy of NA-931 and Tirzepatide in Adults Who Are Overweight or Obese

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