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

COMPLETEDPHASE2

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

NCT06564753•Biomed Industries, Inc.

View on ClinicalTrials.gov

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.

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.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

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

Locations (5)

Biomed Investigational Site

Camperdown, New South Wales, Australia

Biomed Investigational Site

Merewether, New South Wales, Australia

Biomed Investigational Site

St Leonards, New South Wales, Australia

Biomed Investigational Site

Heidelberg Heights, Victoria, Australia

Biomed Investigational Site

Melbourne, Victoria, Australia

Key Dates

Start Date

July 19, 2024

Primary Completion Date

February 27, 2025

Completion Date

April 18, 2025

Last Updated

May 23, 2025

Enrollment

126

ACTUAL participants

Conditions

Weight LossObesityBody WeightBody Weight Changes

Interventions

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

DRUG

Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System

NCT01143454

Metabolic DiseaseObesity+4 more

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RECRUITINGNA

Multi-Acupoint Laser Therapy for Body Shape and Composition in Obese Menopausal Women

NCT07472881

MenopausePerimenopause+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 23, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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