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Completed

NCT Number: NCT06615700

Phase 1 to Study Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NA-931 in Obese Participants and 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.

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Key information

Conditions

Overweight or Obesity Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Type 2 Diabetes

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NA-931

Drug

NA-931 is a quadruple receptor agonist for weight loss

Other names: NA-931 is a quadruple receptor agonist

Placebo

Drug

Placebo of NA-931

Other names: Placebo of NA-931

Primary outcomes

  1. Incidence of Treatment-Emergent Adverse Events in NA-931 participants

    Time frame: 28 days

    To evaluate the safety and tolerability of NA-931

Secondary outcomes

  1. Maximum observe drug concentration (Cmax) of NA-931

    Time frame: 28 days

    Pharmacokinetics (PK) Cmax

  2. 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

Sponsors and collaborators

Lead sponsor

Biomed Industries, Inc.

Industry

Registry information

Official study title

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

Acronym: T2DM

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Sep 27, 2024
Registry last updated
Sep 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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