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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06732245




Registration number
NCT06732245
Ethics application status
Date submitted
9/12/2024
Date registered
13/12/2024

Titles & IDs
Public title
Safety and Efficacy of NA-931 and Tirzepatide in Adults Who Are Overweight or Obese
Scientific 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
Secondary ID [1] 0 0
NA-931-200
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity and Overweight 0 0
Condition category
Condition code
Diet and Nutrition 0 0 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - NA-931
Treatment: Drugs - Tirzepatide
Treatment: Drugs - Tirzepatide
Treatment: Drugs - NA-931
Treatment: Drugs - NA-931
Treatment: Drugs - NA-931
Treatment: Drugs - NA-931 150 mg + no Tirzepatide
Treatment: Drugs - NA-931
Treatment: Drugs - NA-931

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.

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.

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.

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.

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.

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.

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

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.

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.


Treatment: Drugs: NA-931
NA-931 (oral, daily), a quadruple receptor agonist

Tirzepatide (Zepbound) placebo

Treatment: Drugs: Tirzepatide
Tirzepatide (s.c. weekly)

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

* Mounjaro
* Zepbound NA-931 Placebo (oral, daily)

Treatment: Drugs: Tirzepatide
Tirzepatide (s.c. weekly), a Glucagon-like peptide-1 (GLP-1) receptor agonist

• Other Names:

* Mounjaro
* Zepbound

NA-931 Placebo (oral, daily)

Treatment: Drugs: NA-931
NA-931, an oral, daily

• A quadruple receptor agonist

Treatment: Drugs: NA-931
NA-931 (oral, daily), a quadruple receptor agonist

Tirzepatide (s.c. weekly)

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

* Mounjaro
* Zepbound

Treatment: Drugs: NA-931
NA-931 (oral daily), a quadruple receptor agonist

Tirzepatide (s.c. weekly)

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

* Mounjaro
* Zepbound

Treatment: Drugs: NA-931 150 mg + no Tirzepatide
NA-931 150 mg + no Tirzepatide

Treatment: Drugs: NA-931
NA-931 (oral, daily), a quadruple receptor agonist

Tirzepatide (s.c. weekly)

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

* Mounjaro
* Zepbound

Treatment: Drugs: NA-931
NA-931 (oral, daily), a quadruple receptor agonist

Tirzepatide (s.c. weekly)

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

* Mounjaro
* Zepbound
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from baseline in body weight at 48 weeks
Timepoint [1] 0 0
48 weeks
Secondary outcome [1] 0 0
Change from baseline in waist circumference (cm) at 48 weeks
Timepoint [1] 0 0
48 weeks
Secondary outcome [2] 0 0
Change from baseline at 48 weeks in total body fat mass in kilograms (kg)
Timepoint [2] 0 0
48 weeks
Secondary outcome [3] 0 0
Change from baseline at 48 weeks in percent body fat
Timepoint [3] 0 0
48 weeks
Secondary outcome [4] 0 0
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)
Timepoint [4] 0 0
48 weeks
Secondary outcome [5] 0 0
Proportion of participants at 48 weeks with change in waist circumference = 5 cm
Timepoint [5] 0 0
48 weeks
Secondary outcome [6] 0 0
Proportion of participants at 48 weeks with change in Body weight = 5%, = 10% and =15%
Timepoint [6] 0 0
48 weeks
Secondary outcome [7] 0 0
Proportion of participants at 48 weeks with change in Fat mass = 5% = 10% = 15% by Dual energy X-ray absorptiometry (DXA)
Timepoint [7] 0 0
48 weeks
Secondary outcome [8] 0 0
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)
Timepoint [8] 0 0
48 weeks
Secondary outcome [9] 0 0
Percentage of weight loss due to fat mass or lean mass at 48 weeks by dual-energy x-ray absorptiometry (DXA)
Timepoint [9] 0 0
48 weeks
Secondary outcome [10] 0 0
Change from baseline at 48 weeks in fat mass (kg and %) by bioelectrical impedance analysis (BIA)
Timepoint [10] 0 0
48 weeks
Secondary outcome [11] 0 0
Change from baseline at 48 weeks in lean mass (kg and %) and appendicular lean mass by dual-energy x-ray absorptiometry (DXA)
Timepoint [11] 0 0
48 weeks
Secondary outcome [12] 0 0
Change from baseline at 48 weeks in lean mass (kg) by bioelectrical impedance analysis (BIA)
Timepoint [12] 0 0
48 weeks
Secondary outcome [13] 0 0
Safety and tolerability measurements throughout 48 weeks by TEAEs [safety labs, vital signs]
Timepoint [13] 0 0
48 weeks
Secondary outcome [14] 0 0
Proportion of Participants with change from baseline in Body Mass Index (BMI) categories at 48 weeks
Timepoint [14] 0 0
48 weeks
Secondary outcome [15] 0 0
Proportion of Participants with change from baseline in waist-to-height ratio (WHtR ratio) categories at 48 weeks
Timepoint [15] 0 0
48 weeks
Secondary outcome [16] 0 0
Change from baseline in HbA1c (mmol/mol) at 48 weeks
Timepoint [16] 0 0
48 weeks
Secondary outcome [17] 0 0
Change from baseline at 48 weeks in Quality of Life Short Form 36 (SF-36) survey
Timepoint [17] 0 0
48 weeks
Secondary outcome [18] 0 0
Change from Baseline at 48 weeks in Impact of Weight on Quality of Life-Lite for Clinical Trials (IWQOL-Lite)
Timepoint [18] 0 0
48 weeks

Eligibility
Key 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
Minimum age
19 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Factorial
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
15/03/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
15/12/2026
Actual
Sample size
Target
224
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Biomed Research Unit-NSW-2100-109 - Brookvale
Recruitment hospital [2] 0 0
Biomed Research Unit-NSW-2065-110 - Saint Leonards,
Recruitment hospital [3] 0 0
, Australia, 4101 Biomed Research Unit-NSW-4101-111 - South Brisbane,
Recruitment hospital [4] 0 0
Biomed Research Unit-VIC-3124-112 - Camberwell,
Recruitment hospital [5] 0 0
, Victoria, Australia, 3084 Biomed Research Unit-VIC-3084-113 - Heidelberg West
Recruitment postcode(s) [1] 0 0
2100 - Brookvale
Recruitment postcode(s) [2] 0 0
2065 - Saint Leonards,
Recruitment postcode(s) [3] 0 0
4101 - South Brisbane,
Recruitment postcode(s) [4] 0 0
3124 - Camberwell,
Recruitment postcode(s) [5] 0 0
3084 - Heidelberg West
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
New York
Country [4] 0 0
United States of America
State/province [4] 0 0
Texas
Country [5] 0 0
New Zealand
State/province [5] 0 0
Auckland
Country [6] 0 0
New Zealand
State/province [6] 0 0
Wellington
Country [7] 0 0
New Zealand
State/province [7] 0 0
Hamilton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Biomed Industries, Inc.
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Bioneurals Ltd
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Lloyd Tran, PhD
Address 0 0
Biomed Industries, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Lloyd Tran, PhD
Address 0 0
Country 0 0
Phone 0 0
1-800-824-5135
Fax 0 0
Email 0 0
research@biomedind.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06732245