Evaluate HM-002-1005 in Subjects With Type 2 Diabetes Mellitus

NCT06498284 | Completed Phase 1 FDA Drug

• 1 other identifier: HMM0125
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purposes of this study are to:

• Evaluate the safety and tolerability of the study drug.
• Measure how much of the study drug (HM-002-1005) and its breakdown product get into the bloodstream, and how long it takes the body to get rid of them.
• Measure the amount of glucose (blood sugar) and a substance called C-peptide in the bloodstream after receiving the study drug. Researchers will compare the study drug to a placebo (a look-alike substance that contains no drug). Participants will:
• Stay 5 days and 4 nights or 6 days and 5 nights at the research site, and have a follow-up phone call 7 days after leaving the research site.
• Take one (1) dose of the study drug or placebo
• Have blood taken to measure the amount of study drug and its breakdown product and the levels of glucose and C-peptide
• Have safety tests such as vital sign, ECGs, and glucose measurements

Conditions

Diabetes Mellitus, Type II

Keywords

Glucokinase agonist; HM-002-1005; Hyperglycemia; Diabetes Mellitus, Type II; Single dose escalation

Outcome Measures

Primary Outcomes (5)

• Incidence of adverse events

  incidence and severity of adverse events from Day1 to Day 11

  11 Days

• Area under the plasma concentration versus time curve (AUC)

  area under the concentration-time curve from time 0 to 72 hours postdose of HM-002-1005 in plasma

  72 hour

• maximum observed concentration (Cmax)

  Cmax of HM-002-1005 in plasma

  72 hours

• time of the maximum observed concentration (Tmax)

  Tmax of HM-002-1005 in plasma

  72 hours

• apparent terminal elimination half life (t1/2)

  t1/2 of HM-002-1005 in plasma

  72 hours

Secondary Outcomes (1)

• glucose concentration following single oral dose of HM-002-1005

  24 hours

Study Arms (4)

HM-002-1005 61.5 mg or matching placebo

EXPERIMENTAL

Single dose of 61.5 mg HM-002-1005 or matching placebo

Drug: HM-002-1005

HM-002-1005 123 mg or matching placebo

EXPERIMENTAL

Single dose of 123 mg HM-002-1005 or matching placebo

Drug: HM-002-1005

HM-002-1005 184.5 or 246 mg, or matching placebo

EXPERIMENTAL

Single dose of 184.5 or 246 mg HM-002-1005 or matching placebo

Drug: HM-002-1005

HM-002-1005 369 mg or matching placebo

EXPERIMENTAL

Single dose of 369 mg HM-002-1005 or matching placebo

Drug: HM-002-1005

Interventions

HM-002-1005 DRUG

HM-002-1005 extended release tablets for oral administration compared with matching placebo tablets

Also known as: 1005

HM-002-1005 123 mg or matching placebo; HM-002-1005 184.5 or 246 mg, or matching placebo; HM-002-1005 369 mg or matching placebo; HM-002-1005 61.5 mg or matching placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females, of any race, between 18 and 65 years of age, inclusive.
• Body mass index between 18.5 and 38.0 kg/m2, inclusive.
• Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception.
• Type 2 diabetes mellitus, as determined by the American Diabetes Association (ADA) Standard Care Diagnostic Criteria 2023, and
• are drug naïve, treated with diet and exercise, or
• have been on a stable dose of ≤2000 mg metformin for ≥1 month, or
• have been on a stable dose of antidiabetic medications (other than metformin) for ≥90 days.
• Except for findings consistent with T2DM, in good health, determined from medical history, 12 lead electrocardiogram (ECG), vital signs measurements, clinical laboratory evaluations, and physical examinations at screening and/or check in, as assessed by the investigator (or designee).
• Glycated hemoglobin between 6.5% and 9.5%, inclusive.
• Fasting plasma glucose between 126 and 196 mg/dL (7 and 11 mmol/L, respectively), inclusive. Testing may be repeated once, at the discretion of the investigator (or designee).
• Able to comprehend and willing to sign an ICF and to abide by the study restrictions.

You may not qualify if:

• Type 1 diabetes mellitus, maturity onset diabetes of the young, or diabetes mellitus caused by damage to the pancreas or any other condition (eg, acromegaly or Cushing's syndrome).
• Diabetic neuropathy, retinopathy, or nephropathy.
• Acute or chronic metabolic acidosis, including diabetic ketoacidosis.
• History of severe hypoglycemia, defined as severe cognitive impairment requiring external assistance for recovery within 3 months prior to dosing; or recurrent hypoglycemia (Level 2), defined as ≥2 episodes within 3 months prior to dosing; or ADA Level 3 hypoglycemia within 6 months prior to dosing.
• Hypoglycemia unawareness or asymptomatic hypoglycemia.
• Clinically significant history of liver disease (eg, hepatitis and cirrhosis) within 1 year prior to screening.
• Clinically significant history of renal disease. Mild to moderate chronic kidney disease is permitted.
• Clinically significant history of cardiovascular disease, particularly coronary artery disease, arrhythmias, atrial tachycardia, or congestive heart disease within 1 year prior to screening. Managed hypertension is permitted.
• Clinically significant history of any central nervous system disease, including transient ischemic attack, stroke, seizure disorder, depression, or behavioral disturbances within 1 year prior to screening.
• Clinically significant gastric emptying abnormality (eg, severe diabetic gastroparesis or gastric outlet obstruction) or have had gastric bypass surgery.
• Clinically significant or unstable history of any hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, endocrine, or psychiatric disorder, as determined by the investigator (or designee).
• Known or active malignancy, except basal cell carcinoma and cutaneous squamous cell carcinoma.
• Any hospital admission or major surgery within 90 days prior to screening.
• History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, as determined by the investigator (or designee).
• Fasting C peptide \<0.81 ng/mL.

Sponsors & Collaborators

• Hua Medicine Limited: lead

Study Sites (1)

Clinical Pharmacology of Miami

Hialeah, Florida, 33014, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hyperglycemia

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Alexander N Prezioso, MD

  Clinical Pharmacology of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: matching placebo control
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: single oral dose escalation study

Study Record Dates

• First Submitted: April 30, 2024
• First Posted: July 12, 2024
• Study Start: April 25, 2024
• Primary Completion: September 6, 2024
• Study Completion: September 6, 2024
• Last Updated: April 3, 2025

Record last verified: 2025-03

Locations

US (1)