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

Phase 2

Recruiting

• Conditions: Body Weight Changes; Body Weight; Obesity; Weight Loss
• Interventions: Drug: NA-931, dose 1, daily and orally; Drug: NA-931 dose 3, daily and orally; Drug: NA-931, dose2, daily and orally; Drug: NA-931 dose 4, daily and orally

• Registration Number: NCT06564753
• Lead Sponsor: Biomed Industries, Inc.

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.

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 Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-16
• Study Start: 2024-08-19
• Study First Submitted QC: 2024-08-19
• Last Update Submitted: 2024-08-19
• Study First Posted: 2024-08-21
• Last Update Posted: 2024-08-21
• Primary Completion: 2025-01-30
• Study Completion: 2025-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 125

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental: NA-931 - daily orally (Dose #1)	NA-931, dose 1, daily and orally	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
Experimental: NA-931 - daily orally (Dose #3)	NA-931 dose 3, daily and orally	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
Experimental: NA-931 - daily orally (Dose #2)	NA-931, dose2, daily and orally	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
Experimental: NA-931 - daily orally (Dose #4)	NA-931 dose 4, daily and orally	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

Primary Outcome Measures

Name	Time	Method
Percent (relative) change from baseline to Week 13 in body weight	13 weeks	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

Secondary Outcome Measures

Name	Time	Method
Incidence of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse event (TESAEs), adverse events of special interest (AESI)	13 weeks	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
Proportion of Subjects losing ≥5% and ≥10% of baseline weight at Week 13	13 weeks	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

Trial Locations

Locations (1)

Biomed Investigational Site; 🇦🇺 Melbourne, Victoria, Australia