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

B

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

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

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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