Phase 1 to Study Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NA-931 in Obese Participants and Patients With Type 2 Diabetes Mellitus

Phase 1

Completed

• Conditions: Overweight or Obesity; Type 2 Diabetes
• Interventions: Drug: NA-931; Drug: Placebo

• Registration Number: NCT06615700
• Lead Sponsor: 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.

Study Timeline

• Study Start: 2024-05-06
• Primary Completion: 2024-08-12
• Status Verified: 2024-09
• Study Completion: 2024-09-20
• Study First Submitted: 2024-09-24
• Study First Submitted QC: 2024-09-25
• Last Update Submitted: 2024-09-25
• Study First Posted: 2024-09-27
• Last Update Posted: 2024-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Participant Group/Arm- NA-931	NA-931	Experimental: NA-931 Capsule of NA-931 intervention
Participant Group/Arm- Placebo	Placebo	Placebo Comparator: Placebo Capsule of placebo

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events in NA-931 participants	28 days	To evaluate the safety and tolerability of NA-931

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Biomed Industries Pty Limited- Clinical Testing Site 1; 🇦🇺 Camperdown, New South Wales, Australia

Biomed Industries, Pty Limited Testing Site 2; 🇦🇺 Parkville, Victoria, Australia