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CompletedNCT06615700T2DMUpdated Sep 27, 2024

Phase 1 to Study Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NA-931 in Obese Participants and Patients With Type 2 Diabetes Mellitus

A Phase 1 interventional study of NA-931 and Placebo in Overweight or Obesity and Type 2 Diabetes, sponsored by Biomed Industries, Inc.. Completed at 2 sites in Australia. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-27.

Sponsored by Biomed Industries, Inc. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled May 2024, registered Sep 2024).
Phase
Phase 1
Study type
Interventional
Enrollment
74
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the detailed description

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 Type 2 Diabetes Mellitus.

NA-931 is a Quadruple Receptor Agonist for Insulin Like Growth Factor 1 (IGF-1), Glucagon-like Peptide-1 (GLP-1), Gastric Inhibitory Polypeptide (GIP) and Glucagon.

02

Conditions studied

  • Overweight or Obesity
  • Type 2 Diabetes

Keywords

  • NA-931, obesity, Type 2 Diabetes, Biomed Industries, Inc
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 74 is close to the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Biomed Industries, Inc. is the lead sponsor of 9 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion criteria

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
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
74 participants (actual)

Study arms

  • Experimental
    Participant Group/Arm- NA-931

    Experimental: NA-931 Capsule of NA-931 intervention

    Drug: NA-931

  • Placebo comparator
    Participant Group/Arm- Placebo

    Placebo Comparator: Placebo Capsule of placebo

    Drug: Placebo

Interventions

  • DrugNA-931

    NA-931 is a quadruple receptor agonist for weight loss

    Also known as: NA-931 is a quadruple receptor agonist

  • DrugPlacebo

    Placebo of NA-931

    Also known as: Placebo of NA-931

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What researchers measure

Primary outcomes

  1. Incidence of Treatment-Emergent Adverse Events in NA-931 participants

    To evaluate the safety and tolerability of NA-931

    Time frame: 28 days

Secondary outcomes

  1. Maximum observe drug concentration (Cmax) of NA-931

    Pharmacokinetics (PK) Cmax

    Time frame: 28 days

  2. Effect of a High-Fat Meal on Plasma Concentration of NA-931

    Determine the effect of a high-fat meal on the Pharmacokinetics of NA-931following a single dose

    Time frame: 28 days

07

Study locations

2 sites
  • Biomed Industries Pty Limited- Clinical Testing Site 1
    Camperdown, New South Wales 2050, Australia
  • Biomed Industries, Pty Limited Testing Site 2
    Parkville, Victoria 3052, Australia
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 27, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06615700
Lead sponsor
Biomed Industries, Inc.
Responsible party
Sponsor
First posted
Sep 27, 2024
Start date
May 6, 2024
Primary completion
Aug 12, 2024
Completion
Sep 20, 2024
Last update
Sep 27, 2024

Study contacts

Lloyd Tran, PhD
study director · Biomed Industries, Inc.

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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