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

NCT ID: NCT06615700

Last Updated: 2024-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-06

Study Completion Date

2024-09-20

Brief Summary

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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

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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.

Conditions

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Overweight or Obesity Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Participant Group/Arm- NA-931

Experimental: NA-931 Capsule of NA-931 intervention

Group Type EXPERIMENTAL

NA-931

Intervention Type DRUG

NA-931 is a quadruple receptor agonist for weight loss

Participant Group/Arm- Placebo

Placebo Comparator: Placebo Capsule of placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo of NA-931

Interventions

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NA-931

NA-931 is a quadruple receptor agonist for weight loss

Intervention Type DRUG

Placebo

Placebo of NA-931

Intervention Type DRUG

Other Intervention Names

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NA-931 is a quadruple receptor agonist Placebo of NA-931

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Biomed Industries, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lloyd Tran, PhD

Role: STUDY_DIRECTOR

Biomed Industries, Inc.

Locations

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Biomed Industries Pty Limited- Clinical Testing Site 1

Camperdown, New South Wales, Australia

Site Status

Biomed Industries, Pty Limited Testing Site 2

Parkville, Victoria, Australia

Site Status

Countries

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Australia

Other Identifiers

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NA-931-50

Identifier Type: -

Identifier Source: org_study_id

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