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

NCT06615700 | Completed Phase 1 DMC

• 1 other identifier: NA-931-50
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 2

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.

Conditions

Overweight or Obesity; Type 2 Diabetes

Keywords

NA-931, obesity, Type 2 Diabetes, Biomed Industries, Inc

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events in NA-931 participants

  To evaluate the safety and tolerability of NA-931

  28 days

Secondary Outcomes (2)

• Maximum observe drug concentration (Cmax) of NA-931

  28 days

• Effect of a High-Fat Meal on Plasma Concentration of NA-931

  28 days

Study Arms (2)

Participant Group/Arm- NA-931

EXPERIMENTAL

Experimental: NA-931 Capsule of NA-931 intervention

Drug: NA-931

Participant Group/Arm- Placebo

PLACEBO COMPARATOR

Placebo Comparator: Placebo Capsule of placebo

Drug: Placebo

Interventions

NA-931 DRUG

NA-931 is a quadruple receptor agonist for weight loss

Also known as: NA-931 is a quadruple receptor agonist

Participant Group/Arm- NA-931

Placebo DRUG

Placebo of NA-931

Also known as: Placebo of NA-931

Participant Group/Arm- Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biomed Industries, Inc.: lead

Study Sites (2)

Biomed Industries Pty Limited- Clinical Testing Site 1

Camperdown, New South Wales, 2050, Australia

Location

Biomed Industries, Pty Limited Testing Site 2

Parkville, Victoria, 3052, Australia

Location

MeSH Terms

Conditions

Overweight; Obesity; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Officials

• Lloyd Tran, PhD

  Biomed Industries, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2024
• First Posted: September 27, 2024
• Study Start: May 6, 2024
• Primary Completion: August 12, 2024
• Study Completion: September 20, 2024
• Last Updated: September 27, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)