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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
Date last updated
23/05/2025
Titles & IDs
Public title
Phase 2 Trials of NA-931 to Study Subjects Who Are Obese With at Least One Weight-related Comorbid Condition
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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
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Secondary ID [1]
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NA-931-100
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Weight Loss
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Obesity
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Body Weight
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Body Weight Changes
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Condition category
Condition code
Diet and Nutrition
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Other diet and nutrition disorders
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Physical Medicine / Rehabilitation
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Other physical medicine / rehabilitation
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percent (relative) change from baseline to Week 13 in body weight
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Assessment method [1]
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To measure the efficacy of NA-931 for weight loss in adult subjects who are obese, or overweight with at least one weight-related comorbid condition
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Timepoint [1]
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13 weeks
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Secondary outcome [1]
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Proportion of Subjects losing =5% and =10% of baseline weight at Week 13
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Assessment method [1]
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To measure the efficacy of NA-931 for weight loss in adult subjects who are obese, or overweight with at least one weight-related comorbid condition
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Timepoint [1]
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13 weeks
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Secondary outcome [2]
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Incidence of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse event (TESAEs), adverse events of special interest (AESI)
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Assessment method [2]
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To evaluate the safety and tolerability including treatment-emergent adverse events (TEAEs), TESAEs, AESI of NA-931 for weight loss in adult subjects who are obese, or overweight with at least one weight-related comorbid condition
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Timepoint [2]
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13 weeks
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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
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Minimum age
18
Years
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
19/07/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
18/04/2025
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Sample size
Target
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Accrual to date
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Final
126
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Biomed Investigational Site - Camperdown,
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Recruitment hospital [2]
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Biomed Investigational Site - Merewether
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Recruitment hospital [3]
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Biomed Investigational Site - St Leonards
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Recruitment hospital [4]
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Biomed Investigational Site - Heidelberg Heights,
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Recruitment hospital [5]
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Biomed Investigational Site - Melbourne
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Recruitment postcode(s) [1]
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2050 - Camperdown,
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Recruitment postcode(s) [2]
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2291 - Merewether
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Recruitment postcode(s) [3]
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2065 - St Leonards
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Recruitment postcode(s) [4]
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3081 - Heidelberg Heights,
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Recruitment postcode(s) [5]
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3004 - Melbourne
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Biomed Industries, Inc.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a Phase 2 randomized, double-blind, placebo-controlled, parallel arm study of NA-931 in adults who are obese (BMI =30 kg/m2) or who are overweight (BMI =27 kg/m2) with at least one weight-related co-morbid condition.
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Trial website
https://clinicaltrials.gov/study/NCT06564753
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Lloyd Tran, PhD
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Address
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Biomed Industries, Inc.
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Lloyd Tran, PhD
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Address
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Country
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Phone
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1-800-824-5135
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Fax
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Email
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research@biomedind.com
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Contact person for scientific queries
Data sharing statement
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
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