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Obesity drug DA-1726 tested in humans for first time

NCT ID NCT06252220

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage trial tests a new drug called DA-1726 in 139 people with obesity. The main goal is to check safety and side effects. Researchers will also measure how the drug moves through the body and its effect on weight. Participants receive either the drug or a placebo, and neither they nor the doctors know who gets what.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
DA-1726
What this could lead to
If successful, this could lead to a new weight-loss medication for people with obesity.
What could go wrong
This is a very early Phase 1 trial focused on safety, not effectiveness. The drug may not work or could have side effects. Results are years away.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 139 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2024

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Willing and able to provide informed consent prior to initiation of any study specific procedures/activities. 2. Males and females ≥18 to \<=65 years of age, at the time of signing informed consent, who have been diagnosed with obesity, defined by BMI. 3. Except for obesity, otherwise healthy or with stable, well controlled obesity-related conditions as determined by the investigator based on a medical evaluation including physical exam, medical history, laboratory tests, and ECGs. 4. Body mass index (BMI) ≥ 30.0 kg/m2 to 45.0 kg/m2 (Obesity to be confirmed by Caliper test showing body fat percentage with the average or above the average level). 5. Has maintained a stable body weight during the 3 months prior to Screening (\<5% body weight change). 6. Willing to maintain current diet and physical activity regimen. * SAD Cohorts (Be willing to eat a standard diet while in the Clinical Research Unit). * MAD Cohorts (Be willing to eat a standard diet while in the Clinical Research Unit). If appetite decreases, participants may not maintain their current diet. 7. Females must be of non-reproductive potential: * Postmenopausal defined as: * Age of ≥55 years with no menses for at least 12 months; OR * Age \<55 years with no menses for at least 12 months AND with a follicle-stimulating hormone level \>40 IU/L or according to the definition of "postmenopausal range" for the laboratory involved; OR * History of hysterectomy; OR * History of bilateral oophorectomy * History of tubal ligation (surgically sterile) * Note: bilateral salpingectomy is not an accepted sterilization method. 8. Males must agree to practice an acceptable method of effective birth control while on study through 5 half-lives plus one week after receiving last dose of DA-1726. Acceptable methods of birth control include: * Sexual abstinence * Vasectomy and testing that shows there are no sperm in semen. * Condom with spermicide (male) in combination with barrier methods (diaphragm, cervical cap, or cervical sponge), hormonal birth control, or IUS (females) Exclusion Criteria: 1. History or clinical evidence of diabetes mellitus, including a fasting glucose of ≥ 120 mg/dL and/or HbA1c ≥ 6.5% at Screening. 2. Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2). 3. History of cholecystectomy \<= 6 months prior to screening. 4. Subjects with screening calcitonin level of ≥15 pg/mL (calcitonin levels will be monitored during the study). 5. Triglycerides ≥500 mg/dL at Screening. 6. History of pancreatitis. 7. Have a medical history or current evidence of clinically significant cardiac condition as evidenced by any of the following at Screening : * QTc at Screening from locally generated data of \>450 msec in males or \>470 msec in females or history of long QT syndrome * Supine systolic BP higher than 150 mmHg and a supine diastolic BP higher than 95 mmHg at Screening or check-in * Supine HR of \<50 or \>100 beats per minute on 2 of 3 triplicate ECGs at Screening or check-in * Heart block of the 1st, 2nd, or 3rd degree * Sick sinus syndrome (irregular heartbeat patterns) * Disorders in cardiac conduction * Peripheral blood circulation issues * Heart valve conditions * Cardiomyopathy * History of myocardial infarction * Unstable angina * History of heart artery bypass surgery * History of stroke * History of heart failure 8. Regular consumption of caffeine-containing beverages, including coffee, tea, energy drinks, and caffeinated sodas, exceeding 3 cups per day. 9. Current use of tobacco products or having a history of tobacco use within the past 6 months. 10. Have significant previous or current history of comorbidities capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational product; or of interfering with the interpretation of data. 11. History of GI abnormality that could affect GI motility (including small bowel or colonic resection, inflammatory bowel disease, irritable bowel syndrome, gastroparesis \[clinically significant gastric emptying abnormality\], and colon / GI tract cancer). 12. Have a history of chronic medical conditions involving the heart, liver, or kidneys (e.g., atherosclerotic coronary vascular disease (ASCVD), heart failure, liver cirrhosis, chronic kidney disease). 13. Untreated or uncontrolled hypo/hyperthyroidism defined as thyroid-stimulating hormone \>6 mIU/L or \<0.4 mIU/L. 14. Obesity that was induced by other endocrinologic disorders (e.g., Cushing's Syndrome). 15. Evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies. 16. Evidence of hepatitis C and/or positive hepatitis C antibody and hepatitis B, hepatitis B core antibody, and/or positive hepatitis B surface antigen. 17. Have a history or presence of psychiatric disorders that would present a safety risk or may significantly impair the participant's ability to comply with study procedures. 18. Any lifetime history of a suicidal attempt or any suicidal behavior, as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS). 19. History of malignancy of any type, other than basal cell carcinoma, occurring less than 5 years prior to randomization. 20. History of substance abuse (i.e., alcohol or illicit substances) within 12 months prior to Screening; and/or a positive test for alcohol/drugs of abuse at Screening. 21. Previous surgical treatment for obesity or any form of bariatric surgery. 22. Currently receiving treatment in another investigational drug or device study or 5 half lives or 30 days since last dose of investigational drug, whichever is longer. 23. Participants with a history of significant allergic or drug reactions (NSAIDs or antibiotics) or known allergy to DA 1726 excipients that would place them at increased risk. 24. Have received any vaccine ≤30 days prior to check-in. 25. Albumin level \<3.5 g/dL (\<35 g/L) at Screening. 26. Aspartate aminotransferase (AST) ≥1.25 × upper limit of normal (ULN) at Screening. 27. Alanine aminotransferase (ALT) ≥1.25 × upper limit of normal (ULN) at Screening. 28. Bilirubin \>1.25 upper limit of normal (ULN) at Screening. 29. Absolute neutrophil count \<lower limit of normal (LLN) at Screening. 30. Estimated glomerular filtration rate of ≤60 mL/min for women and men (based on the Chronic Kidney Disease Epidemiology Collaboration equation) at the Screening. 31. Fasting low-density lipoprotein ≥160 mg/dL at Screening. 32. Hemoglobin \<LLN at Screening. 33. Platelet count \<LLN at Screening. 34. Current or history of treatment with medications that may cause significant weight gain, within 3 months of Screening, including: * Systemic corticosteroids (except for a short course of treatment, i.e., 7-10 days) * Tricyclic antidepressants * Atypical antipsychotics * Mood stabilizers (e.g., imipramine, amitriptyline, mirtazapine, paroxetine, phenelzine, chlorpromazine, thioridazine, clozapine, olanzapine, valproic acid and its derivatives, and lithium) * Antidiabetic Medications (e.g., insulin or certain sulfonylureas, that may lead to weight gain) * Beta-blockers (e.g., the ones used to treat conditions like hypertension that may cause weight gain) * Antihistamines (particularly the first-generation ones, that may have sedative effects and could potentially contribute to weight gain) * Contraceptives * Any non-steroidal anti-inflammatory drugs 35. Current participation (or within the last 3 months) in an organized weight reduction program or currently using or has used within 3 months prior to Screening: pramlintide, sibutramine, orlistat, zonisamide, topiramate, phentermine, naltrexone, lorcaserin, liraglutide, semaglutide, tirzepatide or metformin.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

  • Contact

    Email: •••••@•••••

Locations

  • Clinical Pharmacology of Miami, LLC

    RECRUITING

    Miami, Florida, 33172, United States

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