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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06564753




Registration number
NCT06564753
Ethics application status
Date submitted
16/08/2024
Date registered
21/08/2024

Titles & IDs
Public title
Phase 2 Trials of NA-931 to Study Subjects Who Are Obese With at Least One Weight-related Comorbid Condition
Scientific title
A Phase 2 Randomized, Double-Blind, Placebo-Controlled, 13-week Study of NA-931 for Weight Management in Subjects Who Are Obese or Overweight With at Least One Weight-related Comorbid Condition
Secondary ID [1] 0 0
NA-931-100
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Weight Loss 0 0
Obesity 0 0
Body Weight 0 0
Body Weight Changes 0 0
Condition category
Condition code
Diet and Nutrition 0 0 0 0
Other diet and nutrition disorders
Physical Medicine / Rehabilitation 0 0 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Drug: Placebo daily and orally
Treatment: Drugs - NA-931, dose 1, daily and orally
Treatment: Drugs - NA-931, dose2, daily and orally
Treatment: Drugs - NA-931 dose 3, daily and orally
Treatment: Drugs - NA-931 dose 4, daily and orally

Placebo comparator: Placebo Comparator: NA-931(Placebo) - Placebo Comparator: NA-931(Placebo) Placebo

Experimental: Experimental: NA-931 - daily orally (Dose #1) - Experimental: NA-931 - daily orally (Dose #1) NA-931 is a peptide quadruple receptor agonist of Insulin-like Growth Hormone 1 (IGF-1), Glucagon-Like Peptide 1 (GLP-1), Glucose-dependent Insulinotropic Polypeptide (GIP), Glucagon Receptor

Experimental: Experimental: NA-931 - daily orally (Dose #2) - Experimental: NA-931 - daily orally (Dose #2) NA-931 is a peptide quadruple receptor agonist of Insulin-like Growth Hormone 1 (IGF-1), Glucagon-Like Peptide 1 (GLP-1), Glucose-dependent Insulinotropic Polypeptide (GIP), Glucagon Receptor

Experimental: Experimental: NA-931 - daily orally (Dose #3) - Experimental: NA-931 - daily orally (Dose #3) NA-931 is a peptide quadruple receptor agonist of Insulin-like Growth Hormone 1 (IGF-1), Glucagon-Like Peptide 1 (GLP-1), Glucose-dependent Insulinotropic Polypeptide (GIP), Glucagon Receptor

Experimental: Experimental: NA-931 - daily orally (Dose #4) - Experimental: NA-931 - daily orally (Dose #4) NA-931 is a peptide quadruple receptor agonist of Insulin-like Growth Hormone 1 (IGF-1), Glucagon-Like Peptide 1 (GLP-1), Glucose-dependent Insulinotropic Polypeptide (GIP), Glucagon Receptor


Treatment: Drugs: Drug: Placebo daily and orally
• Placebo comparator

Treatment: Drugs: NA-931, dose 1, daily and orally
Drug: NA-931 dose 1, daily and orally

• NA-931 is a peptide quadruple GLP-1, IGF-1, GIP , Glucagon quadruple agonist

Treatment: Drugs: NA-931, dose2, daily and orally
Drug: NA-931 dose 2, daily and orally

• NA-931 is a peptide quadruple GLP-1, IGF-1, GIP , Glucagon quadruple agonist

Treatment: Drugs: NA-931 dose 3, daily and orally
Drug: NA-931 dose 3, daily and orally

• NA-931 is a peptide quadruple GLP-1, IGF-1, GIP , Glucagon quadruple agonist

Treatment: Drugs: NA-931 dose 4, daily and orally
Drug: NA-931 dose 4, daily and orally

• NA-931 is a peptide quadruple GLP-1, IGF-1, GIP , Glucagon quadruple agonist
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percent (relative) change from baseline to Week 13 in body weight
Timepoint [1] 0 0
13 weeks
Secondary outcome [1] 0 0
Proportion of Subjects losing =5% and =10% of baseline weight at Week 13
Timepoint [1] 0 0
13 weeks
Secondary outcome [2] 0 0
Incidence of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse event (TESAEs), adverse events of special interest (AESI)
Timepoint [2] 0 0
13 weeks

Eligibility
Key inclusion criteria
1. Age =18 years of age at the time of signing the informed consent
2. Body mass index (BMI) =30 kg/m2 or =27 kg/m2 with at least one weight-related co-morbid condition (treated or untreated), and BMI <50 kg/m2
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. History of or current clinically significant medical or psychiatric disorder that, in the opinion of the Investigator, does not support study participation
2. Self-reported body weight change of 5% or more within 3 months of screening
3. Current or past diagnosis of diabetes mellitus (including type 1, type 2, gestational)
4. Current or past diagnosis of chronic pancreatitis
5. Calcitonin =20 ng/L measured by central laboratory at screening (individuals with elevated calcitonin at initial screening may be re-screened)
6. Any Glucagon-Like Peptide 1 (GLP-1) receptor agonist or GLP-1/ Glucose-dependent Insulinotropic Polypeptide (GIP) dual agonist within 6 months of Screening
7. Any prescription or over-the-counter medications intended for weight loss within 6 months of screening

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 administering the treatment/s

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

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/08/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
28/02/2025
Actual
Sample size
Target
125
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Biomed Investigational Site - Camperdown,
Recruitment hospital [2] 0 0
Biomed Investigational Site - Merewether
Recruitment hospital [3] 0 0
Biomed Investigational Site - St Leonards
Recruitment hospital [4] 0 0
Biomed Investigational Site - Heidelberg Heights,
Recruitment hospital [5] 0 0
Biomed Investigational Site - Melbourne
Recruitment postcode(s) [1] 0 0
2050 - Camperdown,
Recruitment postcode(s) [2] 0 0
2291 - Merewether
Recruitment postcode(s) [3] 0 0
2065 - St Leonards
Recruitment postcode(s) [4] 0 0
3081 - Heidelberg Heights,
Recruitment postcode(s) [5] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Biomed Industries, Inc.
Address
Country

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
The investigators plan to share individual participant data (IPD) available to other researchers.


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/NCT06564753