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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06615700




Registration number
NCT06615700
Ethics application status
Date submitted
24/09/2024
Date registered
27/09/2024
Date last updated
27/09/2024

Titles & IDs
Public title
Phase 1 to Study Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NA-931 in Obese Participants and Patients With Type 2 Diabetes Mellitus
Scientific title
A Randomized, Double-Blind, Placebo-Controlled Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of NA-931 in Overweight/Obese Participants and in Patients With Type 2 Diabetes Mellitus
Secondary ID [1] 0 0
NA-931-50
Universal Trial Number (UTN)
Trial acronym
T2DM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight or Obesity 0 0
Type 2 Diabetes 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes
Diet and Nutrition 0 0 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - NA-931
Treatment: Drugs - Placebo

Experimental: Participant Group/Arm- NA-931 - Experimental: NA-931 Capsule of NA-931 intervention

Placebo comparator: Participant Group/Arm- Placebo - Placebo Comparator: Placebo Capsule of placebo


Treatment: Drugs: NA-931
NA-931 is a quadruple receptor agonist for weight loss

Treatment: Drugs: Placebo
Placebo of NA-931
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of Treatment-Emergent Adverse Events in NA-931 participants
Timepoint [1] 0 0
28 days
Secondary outcome [1] 0 0
Maximum observe drug concentration (Cmax) of NA-931
Timepoint [1] 0 0
28 days
Secondary outcome [2] 0 0
Effect of a High-Fat Meal on Plasma Concentration of NA-931
Timepoint [2] 0 0
28 days

Eligibility
Key inclusion criteria
* Participants 18-65 years old, inclusive
* BMI of 25 - 40, inclusive
* Stable body weight for two months
* Participants must be capable of giving signed informed consent
* Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other clinical study procedures
* Willing to comply with contraception requirements
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* History of significant medical conditions and malignancy
* Uncontrollable hypertension
* History of alcoholism or drug addiction within 1 year prior to Screening
* Current or recent participation in an investigational clinical trial
* Any surgical or medical condition (active or chronic) that may interfere with IP distribution, metabolism, excretion, or drug absorption

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 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/05/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
20/09/2024
Sample size
Target
Accrual to date
Final
74
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Biomed Industries Pty Limited- Clinical Testing Site 1 - Camperdown
Recruitment hospital [2] 0 0
Biomed Industries, Pty Limited Testing Site 2 - Parkville
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
3052 - Parkville

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

Ethics approval
Ethics application status

Summary
Brief summary
A randomized, double-blind, placebo-controlled, dose escalation, first in human study designed to assess the safety and tolerability, pharmacokinetics, and pharmacodynamics of NA-931 when administered as single and multiple-ascending doses in overweight/obese participants and as multiple doses in patients with T2DM.
Trial website
https://clinicaltrials.gov/study/NCT06615700
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06615700