Overweight or Obesity, Type 2 Diabetes
Conditions
Keywords
NA-931, obesity, Type 2 Diabetes, Biomed Industries, Inc
Brief summary
A randomized, double-blind, placebo-controlled, dose escalation, first in human study designed to assess the safety and tolerability, pharmacokinetics, and pharmacodynamics of NA-931 when administered as single and multiple-ascending doses in overweight/obese participants and as multiple doses in patients with T2DM.
Detailed description
A randomized, double-blind, placebo-controlled, dose escalation, first in human study designed to assess the safety and tolerability, pharmacokinetics, and pharmacodynamics of NA-931 when administered as single and multiple-ascending doses in overweight/obese participants and as multiple doses in patients with Type 2 Diabetes Mellitus. NA-931 is a Quadruple Receptor Agonist for Insulin Like Growth Factor 1 (IGF-1), Glucagon-like Peptide-1 (GLP-1), Gastric Inhibitory Polypeptide (GIP) and Glucagon.
Interventions
DRUGNA-931
NA-931 is a quadruple receptor agonist for weight loss
DRUGPlacebo
Placebo of NA-931
Sponsors
Biomed Industries, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Participants 18-65 years old, inclusive * BMI of 25 - 40, inclusive * Stable body weight for two months * Participants must be capable of giving signed informed consent * Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other clinical study procedures * Willing to comply with contraception requirements
Exclusion criteria
* History of significant medical conditions and malignancy * Uncontrollable hypertension * History of alcoholism or drug addiction within 1 year prior to Screening * Current or recent participation in an investigational clinical trial * Any surgical or medical condition (active or chronic) that may interfere with IP distribution, metabolism, excretion, or drug absorption
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events in NA-931 participants | 28 days | To evaluate the safety and tolerability of NA-931 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum observe drug concentration (Cmax) of NA-931 | 28 days | Pharmacokinetics (PK) Cmax |
| Effect of a High-Fat Meal on Plasma Concentration of NA-931 | 28 days | Determine the effect of a high-fat meal on the Pharmacokinetics of NA-931following a single dose |
Countries
Australia
Outcome results
None listed