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Phase 2 Trials of NA-931 to Study Subjects Who Are Obese With at Least One Weight-related Comorbid Condition
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.
Study details:
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
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2024-08-19
Primary completion: 2025-01-30
Study completion finish: 2025-02-28
Study type
TREATMENT
Phase
PHASE2
Trial ID
NCT06564753
Intervention or treatment
DRUG: Drug: Placebo daily and orally
DRUG: NA-931, dose 1, daily and orally
DRUG: NA-931, dose2, daily and orally
DRUG: NA-931 dose 3, daily and orally
DRUG: NA-931 dose 4, daily and orally
Conditions
- • Weight Loss
- • Obesity
- • Body Weight
- • Body Weight Changes
Find a site
Closest Location:
Biomed Investigational Site
Research sites nearby
Select from list below to view details:
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
PLACEBO_COMPARATOR: Placebo Comparator: NA-931(Placebo)
| DRUG: Drug: Placebo daily and orally
|
EXPERIMENTAL: Experimental: NA-931 - daily orally (Dose #1)
| DRUG: NA-931, dose 1, daily and orally
|
EXPERIMENTAL: Experimental: NA-931 - daily orally (Dose #2)
| DRUG: NA-931, dose2, daily and orally
|
EXPERIMENTAL: Experimental: NA-931 - daily orally (Dose #3)
| DRUG: NA-931 dose 3, daily and orally
|
EXPERIMENTAL: Experimental: NA-931 - daily orally (Dose #4)
| DRUG: NA-931 dose 4, daily and orally
|
What is the study measuring?
Primary outcome
| Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
|---|---|---|
| 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 | 13 weeks |
Secondary outcome
| Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
|---|---|---|
| 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 | 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 | 13 weeks |
Frequently Asked Questions
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