Phase 1 Type 2 Diabetes Trial, Not Yet Recruiting NCT07548957 Sponsor: Korea United Pharm. Inc. Condition: Type 2 Diabetes
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Phase 1 Type 2 Diabetes Trial, Not Yet Recruiting

NCT07548957
Not Yet Recruiting Phase 1

voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice

Who may and may not be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who may be able to join

  • People aged 19 years or older at the time of the screening visit.
  • People who weigh at least 50 kg (or at least 45 kg for females) and have a body mass index (BMI) between 18.0 and 30.0 at the screening visit.
  • People who do not have any significant long-term or inherited health conditions, and who show no concerning symptoms or findings at the screening visit.
  • People whose blood tests, urine tests, and heart tracing (ECG) results are considered acceptable by the trial investigator.
  • People who agree to use an approved non-hormonal form of contraception (such as condoms, an intrauterine device, vasectomy, or tubal ligation) from the first dose until 7 weeks after the last dose, and who agree not to donate sperm or eggs during this time.
  • People who have voluntarily signed a consent form after being fully informed about the trial's purpose, procedures, the study treatment, and possible side effects.

Who may not be able to join

Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.

  • People who have, or have a history of, significant illness affecting the digestive system, heart and blood vessels, hormones, lungs, blood, infections, kidneys, mental health or nervous system, muscles and joints, immune system, ears/nose/throat, skin, or eyes.
  • People who have had stomach or bowel surgery (other than a simple appendix removal or hernia repair) that could affect how a drug is absorbed, or who have digestive tract conditions.
  • People who have taken medications that speed up or slow down drug processing in the body within 1 month before the first dose, or any medications that could affect the trial within 10 days before the first dose (confirm with trial site regarding specific medications).
  • People who have taken part in another clinical trial or bioequivalence study and received a study treatment within the 6 months before the first dose.
  • People who have donated whole blood within the past 8 weeks, donated blood components within the past 2 weeks, or received a blood transfusion within the past 4 weeks before the first dose.
  • Males who have consumed more than an average of 21 alcoholic drinks per week in the month before the first dose (where 1 drink equals 50 mL of soju, 30 mL of spirits, or 250 mL of beer).
  • Females who have consumed more than an average of 14 alcoholic drinks per week in the month before the first dose (using the same drink measures above).
  • People who have smoked more than an average of 20 cigarettes per day in the month before the first dose.
  • People who have a known allergy or sensitivity to the active ingredient, any component of the study treatment, or any drug in the same family as the study treatment.
  • People with inherited conditions affecting the body's ability to process certain sugars, such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
  • People who have Type 1 diabetes, lactic acidosis, any form of acute or chronic metabolic acidosis including diabetic ketoacidosis, or a history of ketoacidosis.
  • People with moderate to severe kidney problems (with a filtration rate below 45 mL/min/1.73 m²), or conditions that could suddenly reduce kidney function such as severe dehydration, serious infection, cardiovascular collapse, heart attack, or sepsis.
  • People with acute or unstable heart failure.
  • People who are scheduled to undergo a medical imaging procedure that uses iodine-based dye injected into the bloodstream (such as a contrast CT scan or angiography).
  • People who are in a state of pre-diabetic coma.
  • People with severe infections or serious widespread injuries or trauma.
  • People who are scheduled for surgery.
  • People with malnutrition, starvation, significant physical weakness, or conditions affecting hormone-producing glands such as the pituitary or adrenal glands.
  • People with acute or ongoing conditions that may reduce oxygen supply to body tissues, such as liver problems, respiratory failure, heart attack, or shock.
  • People with heavy alcohol intake or digestive problems such as dehydration, ongoing diarrhoea, or vomiting.
  • People considered unsuitable for participation by the trial investigator for any other reason.
  • People who are pregnant, possibly pregnant, or currently breastfeeding.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 30 July 2026

Contact this trial

Phone: +82 070-4665-9490

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Not Yet Recruiting
Phase
Phase 1
Sponsor
Korea United Pharm. Inc.
Registry
ClinicalTrials.gov
Start date
1 April 2026
Est. completion
1 August 2026

This date has passed while the registry still lists the trial as open to participants. Sponsors often update a trial's status without revising its projected end date, so it may well still be recruiting — but the record is out of date in at least one respect. Check with the study contact before relying on either.

Where this trial is recruiting

🇰🇷 South Korea

Primary endpoints

AUCt; Cmax

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 30 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov