Clinical trial NCT06564753: Phase 2 Trials of NA-931 to Study Subjects Who Are Obese With at Least One Weight-related Comorbid Condition
Official title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled, 13-week Study of NA-931 for Weight Management in Subjects Who Are Obese or Overweight With at Least One Weight-related Comorbid Condition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Weight Loss
Obesity
Body Weight
Body Weight Changes
Keywords: Obesity
Overweight
Weight Loss
Lead sponsor: Biomed Industries, Inc.
Sponsor class: INDUSTRY
First posted: 2024-08-21
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized, double-blind, placebo-controlled, parallel arm study
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percent (relative) change from baseline to Week 13 in body weight
timeFrame: 13 weeks
Secondary outcomes:
measure: Proportion of Subjects losing ≥5% and ≥10% of baseline weight at Week 13
timeFrame: 13 weeks
measure: Incidence of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse event (TESAEs), adverse events of special interest (AESI)
timeFrame: 13 weeks
Other outcomes:
Locations:
city: Camperdown,
country: Australia
facility: Biomed Investigational Site
state: New South Wales
city: Merewether
country: Australia
facility: Biomed Investigational Site
state: New South Wales
city: St Leonards
country: Australia
facility: Biomed Investigational Site
state: New South Wales
city: Heidelberg Heights,
country: Australia
facility: Biomed Investigational Site
state: Victoria
city: Melbourne
country: Australia
facility: Biomed Investigational Site
state: Victoria
Study officials:
affiliation: Biomed Industries, Inc.
name: Lloyd Tran, PhD
role: PRINCIPAL_INVESTIGATOR
References: