Phase 1 to Study Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NA-931 in Obese Participants and Patients With Type 2 Diabetes Mellitus (T2DM)

Biomed Industries

Status and phase: Completed; Phase 1

Conditions: Overweight or Obesity; Type 2 Diabetes

Treatments: Drug: NA-931; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06615700

NA-931-50

Details and patient eligibility

About

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.

Full 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.

Enrollment: 74 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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74 participants in 2 patient groups, including a placebo group

Participant Group/Arm- NA-931

Experimental group

Description:

Experimental: NA-931 Capsule of NA-931 intervention

Treatment:

Drug: NA-931

Participant Group/Arm- Placebo

Placebo Comparator group

Description:

Placebo Comparator: Placebo Capsule of placebo

Treatment:

Drug: Placebo