Phase 1 to Study Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NA-931 in Obese Participants and Patients With Type 2 Diabetes Mellitus (T2DM)

September 25, 2024 updated by: Biomed Industries, Inc.

A Randomized, Double-Blind, Placebo-Controlled Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of NA-931 in Overweight/Obese Participants and in Patients With Type 2 Diabetes Mellitus

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

74

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Biomed Industries Pty Limited- Clinical Testing Site 1
    • Victoria
      • Parkville, Victoria, Australia, 3052
        • Biomed Industries, Pty Limited Testing Site 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

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?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Participant Group/Arm- NA-931
Experimental: NA-931 Capsule of NA-931 intervention
Drug: NA-931
NA-931 is a quadruple receptor agonist for weight loss
Other Names:
  • NA-931 is a quadruple receptor agonist
Placebo Comparator: Participant Group/Arm- Placebo
Placebo Comparator: Placebo Capsule of placebo
Drug: Placebo
Placebo of NA-931
Other Names:
  • Placebo of NA-931

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Treatment-Emergent Adverse Events in NA-931 participants
Time Frame: 28 days
To evaluate the safety and tolerability of NA-931
28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum observe drug concentration (Cmax) of NA-931
Time Frame: 28 days
Pharmacokinetics (PK) Cmax
28 days
Effect of a High-Fat Meal on Plasma Concentration of NA-931
Time Frame: 28 days
Determine the effect of a high-fat meal on the Pharmacokinetics of NA-931following a single dose
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biomed Industries, Inc.

Investigators

  • Study Director: Lloyd Tran, PhD, Biomed Industries, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 6, 2024

Primary Completion (Actual)

August 12, 2024

Study Completion (Actual)

September 20, 2024

Study Registration Dates

First Submitted

September 24, 2024

First Submitted That Met QC Criteria

September 25, 2024

First Posted (Actual)

September 27, 2024

Study Record Updates

Last Update Posted (Actual)

September 27, 2024

Last Update Submitted That Met QC Criteria

September 25, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NA-931-50

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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