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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Body Weight; Weight Loss; Body Weight Changes
• Intervention / Treatment: Drug: Drug: Placebo daily and orally; Drug: NA-931, dose 1, daily and orally; Drug: NA-931, dose2, daily and orally; Drug: NA-931 dose 3, daily and orally; Drug: NA-931 dose 4, daily and orally

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.

• Study Type: Interventional
• Enrollment (Actual): 126
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Comparator: NA-931(Placebo); Placebo Comparator: NA-931(Placebo) Placebo	Drug: Drug: Placebo daily and orally; • Placebo comparator; Other Names: NA-931 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	Drug: 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; Other Names: NA-931
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; Drug: NA-931 dose 2, daily and orally • NA-931 is a peptide quadruple GLP-1, IGF-1, GIP , Glucagon quadruple agonist; Other Names: NA-931
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; Drug: NA-931 dose 3, daily and orally • NA-931 is a peptide quadruple GLP-1, IGF-1, GIP , Glucagon quadruple agonist; Other Names: NA=931
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; Drug: NA-931 dose 4, daily and orally • NA-931 is a peptide quadruple GLP-1, IGF-1, GIP , Glucagon quadruple agonist; Other Names: NA-931

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	13 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	13 weeks
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	13 weeks

Collaborators and Investigators

• Sponsor: Biomed Industries, Inc.
• Collaborators: Biomed Industries, Inc.
• Investigators: Principal Investigator: Lloyd Tran, PhD, Biomed Industries, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2024
• Primary Completion (Actual): February 27, 2025
• Study Completion (Actual): April 18, 2025

Study Registration Dates

• First Submitted: August 16, 2024
• First Submitted That Met QC Criteria: August 19, 2024
• First Posted (Actual): August 21, 2024

Study Record Updates

• Last Update Posted (Actual): May 23, 2025
• Last Update Submitted That Met QC Criteria: May 20, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Obesity; Overweight; Weight Loss
• Additional Relevant MeSH Terms: Weight Loss; Body Weight; Body Weight Changes
• Other Study ID Numbers: NA-931-100

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The investigators plan to share individual participant data (IPD) available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No