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Weight LossPhase 2NCT06564753

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

A Phase 2 study testing NA-931, dose 1, daily and orally, NA-931, dose2, daily and orally and NA-931 dose 3, daily and orally in people with Weight Loss and Obesity, run by Biomed Industries, Inc. at 5 sites in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Weight Loss, Obesity, Body Weight
What is being tested?
NA-931, dose 1, daily and orally, NA-931, dose2, daily and orally and NA-931 dose 3, daily and orally
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
126 participants
Where
5 sitesAustralia
Study dates
19 Jul 2024to 18 Apr 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥18 years of age at the time of signing the informed consent
  • 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

Who cannot join

  • History of or current clinically significant medical or psychiatric disorder that, in the opinion of the Investigator, does not support study participation
  • Self-reported body weight change of 5% or more within 3 months of screening
  • Current or past diagnosis of diabetes mellitus (including type 1, type 2, gestational)
  • Current or past diagnosis of chronic pancreatitis
  • Calcitonin ≥20 ng/L measured by central laboratory at screening (individuals with elevated calcitonin at initial screening may be re-screened)
  • Any Glucagon-Like Peptide 1 (GLP-1) receptor agonist or GLP-1/ Glucose-dependent Insulinotropic Polypeptide (GIP) dual agonist within 6 months of Screening
  • Any prescription or over-the-counter medications intended for weight loss within 6 months of screening

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Australia5 sites

  • Biomed Investigational Site

    Camperdown, New South Wales, 2050

  • Biomed Investigational Site

    Heidelberg Heights, Victoria, 3081

  • Biomed Investigational Site

    Melbourne, Victoria, 3004

  • Biomed Investigational Site

    Merewether, New South Wales, 2291

  • Biomed Investigational Site

    St Leonards, New South Wales, 2065

Other trials in Australia

About this study

Official 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

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.

Being tested
Drug: Placebo daily and orally, NA-931, dose 1, daily and orally, NA-931, dose2, daily and orally, NA-931 dose 3, daily and orally, NA-931 dose 4, daily and orally
Keywords
Obesity, Overweight, Weight Loss
Medical subject headings
Weight Loss, Obesity, Body Weight, Body Weight Changes, Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Drug: Placebo daily and orallyDrug

    Also called NA-931 placebo

    • Placebo comparator

  • NA-931, dose 1, daily and orallyDrug

    Also called NA-931

    Drug: NA-931 dose 1, daily and orally

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

  • NA-931, dose2, daily and orallyDrug

    Also called NA-931

    Drug: NA-931 dose 2, daily and orally

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

  • NA-931 dose 3, daily and orallyDrug

    Also called NA=931

    Drug: NA-931 dose 3, daily and orally

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

  • NA-931 dose 4, daily and orallyDrug

    Also called NA-931

    Drug: NA-931 dose 4, daily and orally

    • NA-931 is a peptide quadruple GLP-1, IGF-1, GIP , Glucagon quadruple agonist
Study groups in NCT06564753
Study groupRoleWhat they receive
Placebo Comparator: NA-931(Placebo)Placebo comparatorPlacebo Comparator: NA-931(Placebo) Placebo
Receives: Drug: Drug: Placebo daily and orally
Experimental: NA-931 - daily orally (Dose #1)ExperimentalExperimental: 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
Receives: Drug: NA-931, dose 1, daily and orally
Experimental: NA-931 - daily orally (Dose #2)ExperimentalExperimental: 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
Receives: Drug: NA-931, dose2, daily and orally
Experimental: NA-931 - daily orally (Dose #3)ExperimentalExperimental: 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
Receives: Drug: NA-931 dose 3, daily and orally
Experimental: NA-931 - daily orally (Dose #4)ExperimentalExperimental: 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
Receives: Drug: NA-931 dose 4, daily and orally

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 13 weeks

Secondary outcomes (2)

  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

    Measured: 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

    Measured: 13 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2024
  2. Study start19 Jul 2024
  3. Primary completion27 Feb 2025
  4. Study completion18 Apr 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
randomized, double-blind, placebo-controlled, parallel arm study
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
126 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06564753
Sponsor's protocol ID
NA-931-100
Status last verified
May 2025
First submitted
16 Aug 2024
Last updated
23 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The investigators plan to share individual participant data (IPD) available to other researchers.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing NA-931, dose 1, daily and orally, NA-931, dose2, daily and orally and NA-931 dose 3, daily and orally in people with Weight Loss and Obesity, run by Biomed Industries, Inc. at 5 sites in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent (relative) change from baseline to Week 13 in body weight (time frame: 13 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06564753.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2025.

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