Search / Trial NCT06615700

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

Launched by BIOMED INDUSTRIES, INC. · Sep 25, 2024

Trial Information

Current as of October 03, 2024

Completed

Keywords

Na 931, Obesity, Type 2 Diabetes, Biomed Industries, Inc

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.

Gender

ALL

Eligibility criteria

  • 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

About Sponsor

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Camperdown, New South Wales, Australia

Parkville, Victoria, Australia

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0