Status:
COMPLETED
Phase 2 Trials of NA-931 to Study Subjects Who Are Obese With at Least One Weight-related Comorbid Condition
Lead Sponsor:
Biomed Industries, Inc.
Conditions:
Weight Loss
Obesity
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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-rela...
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 pharmacokine...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
July 19 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 18 2025
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT06564753
Start Date
July 19 2024
End Date
April 18 2025
Last Update
May 23 2025
Active Locations (5)
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1
Biomed Investigational Site
Camperdown, New South Wales, Australia, 2050
2
Biomed Investigational Site
Merewether, New South Wales, Australia, 2291
3
Biomed Investigational Site
St Leonards, New South Wales, Australia, 2065
4
Biomed Investigational Site
Heidelberg Heights, Victoria, Australia, 3081