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CompletedNCT06564753Updated May 23, 2025

Phase 2 Trials of NA-931 to Study Subjects Who Are Obese With at Least One Weight-related Comorbid Condition

A Phase 2 interventional study of Drug: Placebo daily and orally and NA-931, dose 1, daily and orally in Weight Loss, Obesity and Body Weight, sponsored by Biomed Industries, Inc.. Completed at 5 sites in Australia. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-05-23.

Sponsored by Biomed Industries, Inc. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
126
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the detailed description

This is a Phase 2, 13-week randomized, double-blind, placebo-controlled, parallel arm study that will evaluate the safety, tolerability, weight loss efficacy, pharmacodynamic effects, and pharmacokinetics 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.

02

Conditions studied

  • Weight Loss
  • Obesity
  • Body Weight
  • Body Weight Changes

Keywords

  • Obesity
  • Overweight
  • Weight Loss
03

In context

Body Weight

1,223 studies on the registry are indexed under Body Weight; 131 are open to participants now.

This study's enrollment of 126 is above the median of 64 across 947 interventional studies indexed under Body Weight.

Browse Body Weight 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 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion criteria

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
126 participants (actual)

Study arms

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

    Placebo Comparator: NA-931(Placebo) Placebo

    Drug: Drug: Placebo daily and orally

  • 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

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

  • 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

    Drug: NA-931, dose2, daily and orally

  • 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

    Drug: NA-931 dose 3, daily and orally

  • 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

    Drug: NA-931 dose 4, daily and orally

Interventions

  • DrugDrug: Placebo daily and orally

    • Placebo comparator

    Also known as: NA-931 placebo

  • DrugNA-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

    Also known as: NA-931

  • DrugNA-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

    Also known as: NA-931

  • DrugNA-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

    Also known as: NA=931

  • DrugNA-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

    Also known as: NA-931

06

What researchers measure

Primary outcomes

  1. Percent (relative) change from baseline to Week 13 in body weight

    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

    Time frame: 13 weeks

Secondary outcomes

  1. Proportion of Subjects losing ≥5% and ≥10% of baseline weight at Week 13

    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

    Time frame: 13 weeks

  2. Incidence of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse event (TESAEs), adverse events of special interest (AESI)

    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

    Time frame: 13 weeks

07

Study locations

5 sites
  • Biomed Investigational Site
    Camperdown,, New South Wales 2050, Australia
  • Biomed Investigational Site
    Merewether, New South Wales 2291, Australia
  • Biomed Investigational Site
    St Leonards, New South Wales 2065, Australia
  • Biomed Investigational Site
    Heidelberg Heights,, Victoria 3081, Australia
  • Biomed Investigational Site
    Melbourne, Victoria 3004, Australia
08

References and documents

Individual participant data

Plan to share: No — The investigators plan to share individual participant data (IPD) available to other researchers.

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 May 23, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06564753
Lead sponsor
Biomed Industries, Inc.
Responsible party
Sponsor
First posted
Aug 21, 2024
Start date
Jul 19, 2024
Primary completion
Feb 27, 2025
Completion
Apr 18, 2025
Last update
May 23, 2025

Study contacts

Lloyd Tran, PhD
principal investigator · Biomed Industries, Inc.

Oversight

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

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This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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