Clinical trial NCT06615700: Phase 1 to Study Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NA-931 in Obese Participants and Patients With Type 2 Diabetes Mellitus
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Overweight or Obesity
Type 2 Diabetes
Keywords: NA-931, obesity, Type 2 Diabetes, Biomed Industries, Inc
Lead sponsor: Biomed Industries, Inc.
Sponsor class: INDUSTRY
First posted: 2024-09-27
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events in NA-931 participants
timeFrame: 28 days
Secondary outcomes:
measure: Maximum observe drug concentration (Cmax) of NA-931
timeFrame: 28 days
measure: Effect of a High-Fat Meal on Plasma Concentration of NA-931
timeFrame: 28 days
Other outcomes:
Locations:
city: Camperdown
country: Australia
facility: Biomed Industries Pty Limited- Clinical Testing Site 1
state: New South Wales
city: Parkville
country: Australia
facility: Biomed Industries, Pty Limited Testing Site 2
state: Victoria
Study officials:
affiliation: Biomed Industries, Inc.
name: Lloyd Tran, PhD
role: STUDY_DIRECTOR
References: