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

Last updated: May 20, 2025
Sponsor: Biomed Industries, Inc.
Overall Status: Completed

Phase

2

Condition

Body Composition

Diabetes Prevention

Obesity

Treatment

NA-931 dose 3, daily and orally

Drug: Placebo daily and orally

NA-931, dose2, daily and orally

Clinical Study ID

NCT06564753
NA-931-100
  • Ages 18-70
  • All Genders

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.

Eligibility Criteria

Inclusion

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-relatedco-morbid condition (treated or untreated), and BMI <50 kg/m2

Exclusion

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 withelevated calcitonin at initial screening may be re-screened)

  6. Any Glucagon-Like Peptide 1 (GLP-1) receptor agonist or GLP-1/ Glucose-dependentInsulinotropic Polypeptide (GIP) dual agonist within 6 months of Screening

  7. Any prescription or over-the-counter medications intended for weight loss within 6months of screening

Study Design

Total Participants: 126
Treatment Group(s): 5
Primary Treatment: NA-931 dose 3, daily and orally
Phase: 2
Study Start date:
July 19, 2024
Estimated Completion Date:
April 18, 2025

Study 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.

Connect with a study center

  • Biomed Investigational Site

    Camperdown,, New South Wales 2050
    Australia

    Site Not Available

  • Biomed Investigational Site

    Merewether, New South Wales 2291
    Australia

    Site Not Available

  • Biomed Investigational Site

    St Leonards, New South Wales 2065
    Australia

    Site Not Available

  • Biomed Investigational Site

    Heidelberg Heights,, Victoria 3081
    Australia

    Site Not Available

  • Biomed Investigational Site

    Melbourne, Victoria 3004
    Australia

    Site Not Available

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