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

Biomed Industries, Inc.126 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

126

Conditions

Weight Loss Obesity Body Weight Body Weight Changes

Interventions

Drug: Placebo daily and orallyDRUG

• Placebo comparator

NA-931, dose 1, daily and orallyDRUG

Drug: NA-931 dose 1, daily and orally • NA-931 is a peptide quadruple GLP-1, IGF-1, GIP , Glucagon quadruple agonist

NA-931, dose2, daily and orallyDRUG

Drug: NA-931 dose 2, daily and orally • NA-931 is a peptide quadruple GLP-1, IGF-1, GIP , Glucagon quadruple agonist

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 13 weeks

Secondary Outcomes

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

Time frame: 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

Time frame: 13 weeks

Data from ClinicalTrials.gov

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