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

Phase 2

Recruiting

• Conditions: Weight Loss; Obesity; Body Weight; Body Weight Changes

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-8-16
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria:<br><br> 1. Age =18 years of age at the time of signing the informed consent<br><br> 2. Body mass index (BMI) =30 kg/m2 or =27 kg/m2 with at least one weight-related<br> co-morbid condition (treated or untreated), and BMI <50 kg/m2<br><br>Exclusion Criteria:<br><br> 1. History of or current clinically significant medical or psychiatric disorder that,<br> in the opinion of the Investigator, does not support study participation<br><br> 2. Self-reported body weight change of 5% or more within 3 months of screening<br><br> 3. Current or past diagnosis of diabetes mellitus (including type 1, type 2,<br> gestational)<br><br> 4. Current or past diagnosis of chronic pancreatitis<br><br> 5. Calcitonin =20 ng/L measured by central laboratory at screening (individuals with<br> elevated calcitonin at initial screening may be re-screened)<br><br> 6. Any Glucagon-Like Peptide 1 (GLP-1) receptor agonist or GLP-1/ Glucose-dependent<br> Insulinotropic Polypeptide (GIP) dual agonist within 6 months of Screening<br><br> 7. Any prescription or over-the-counter medications intended for weight loss within 6<br> months of screening

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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