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

NCT06564753 | Completed Phase 2 DMC

• 1 other identifier: NA-931-100
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Weight Loss; Obesity; Body Weight; Body Weight Changes

Keywords

Obesity; Overweight; Weight Loss

Outcome Measures

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

  13 weeks

Secondary Outcomes (2)

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

  13 weeks

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

  13 weeks

Study Arms (5)

Placebo Comparator: NA-931(Placebo)

PLACEBO COMPARATOR

Placebo Comparator: NA-931(Placebo) Placebo

Drug: Drug: Placebo daily and orally

Experimental: NA-931 - daily orally (Dose #1)

EXPERIMENTAL

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: NA-931 - daily orally (Dose #2)

EXPERIMENTAL

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: NA-931 - daily orally (Dose #3)

EXPERIMENTAL

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: NA-931 - daily orally (Dose #4)

EXPERIMENTAL

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

Drug: Placebo daily and orally DRUG

• Placebo comparator

Also known as: NA-931 placebo

Placebo Comparator: NA-931(Placebo)

NA-931, dose 1, daily and orally DRUG

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

Experimental: NA-931 - daily orally (Dose #1)

NA-931, dose2, daily and orally DRUG

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

Experimental: NA-931 - daily orally (Dose #2)

NA-931 dose 3, daily and orally DRUG

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

Experimental: NA-931 - daily orally (Dose #3)

NA-931 dose 4, daily and orally DRUG

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

Experimental: NA-931 - daily orally (Dose #4)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biomed Industries, Inc.: lead

Study Sites (5)

Biomed Investigational Site

Camperdown, New South Wales, 2050, Australia

Location

Biomed Investigational Site

Merewether, New South Wales, 2291, Australia

Location

Biomed Investigational Site

St Leonards, New South Wales, 2065, Australia

Location

Biomed Investigational Site

Heidelberg Heights, Victoria, 3081, Australia

Location

Biomed Investigational Site

Melbourne, Victoria, 3004, Australia

Location

MeSH Terms

Conditions

Weight Loss; Obesity; Body Weight; Body Weight Changes; Overweight

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Lloyd Tran, PhD

  Biomed Industries, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: randomized, double-blind, placebo-controlled, parallel arm study

Study Record Dates

• First Submitted: August 16, 2024
• First Posted: August 21, 2024
• Study Start: July 19, 2024
• Primary Completion: February 27, 2025
• Study Completion: April 18, 2025
• Last Updated: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (5)