BridgeMD
New treatment option for Obesity
Official title First in Human Study in Subjects With Obesity, But Otherwise Healthy
ClinicalTrials.gov ID: NCT06252220
What this study is testing
What is DA-1726?
DA-1726 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for obesity.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a First in Human study to evaluate the safety and tolerability of DA-1726 following single and multiple doses in participants with obesity, but otherwise healthy subjects.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Willing and able to provide informed consent prior to initiation of any study specific procedures/activities.
- 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.
- Except for obesity, otherwise healthy or with stable, well controlled obesity-related conditions as determined by the investigator based on a medical...
- 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...
- Has maintained a stable body weight during the 3 months prior to Screening (\<5% body weight change).
You likely can't join if
- History or clinical evidence of diabetes mellitus, including a fasting glucose of ≥ 120 mg/dL and/or HbA1c ≥ 6.5% at Screening.
- Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2).
- History of cholecystectomy \<= 6 months prior to screening.
- people with screening calcitonin level of ≥15 pg/mL (calcitonin levels will be monitored during the study).
- Triglycerides ≥500 mg/dL at Screening.
- History of pancreatitis.
See the full eligibility criteria
Who can join
- Willing and able to provide informed consent prior to initiation of any study specific procedures/activities.
- 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.
- 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...
- 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).
- Has maintained a stable body weight during the 3 months prior to Screening (\<5% body weight change).
- 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.
- Females must be of non-reproductive potential:
- Postmenopausal defined as:
- Age of ≥55 years with no menses for at least 12 months; OR
- Age \ 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.
- 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)
What rules you out
- History or clinical evidence of diabetes mellitus, including a fasting glucose of ≥ 120 mg/dL and/or HbA1c ≥ 6.5% at Screening.
- Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2).
- History of cholecystectomy \<= 6 months prior to screening.
- people with screening calcitonin level of ≥15 pg/mL (calcitonin levels will be monitored during the study).
- Triglycerides ≥500 mg/dL at Screening.
- History of pancreatitis.
- 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 \ 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
- Regular consumption of caffeine-containing beverages, including coffee, tea, energy drinks, and caffeinated sodas, exceeding 3 cups per day.
- Current use of tobacco products or having a history of tobacco use within the past 6 months.
- 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...
- 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...
- 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).
- Untreated or uncontrolled hypo/hyperthyroidism defined as thyroid-stimulating hormone \>6 mIU/L or \<0.4 mIU/L.
- Obesity that was induced by other endocrinologic disorders (e.g., Cushing's Syndrome).
- Evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies.
- Evidence of hepatitis C and/or positive hepatitis C antibody and hepatitis B, hepatitis B core antibody, and/or positive hepatitis B surface antigen.
- 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.
- Any lifetime history of a suicidal attempt or any suicidal behavior, as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS).
- History of malignancy of any type, other than basal cell carcinoma, occurring less than 5 years prior to randomization.
- 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.
- Previous surgical treatment for obesity or any form of bariatric surgery.
- 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.
- 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.
- Have received any vaccine ≤30 days prior to check-in.
- Albumin level \<3.5 g/dL (\<35 g/L) at Screening.
- Aspartate aminotransferase (AST) ≥1.25 × upper limit of normal (ULN) at Screening.
- Alanine aminotransferase (ALT) ≥1.25 × upper limit of normal (ULN) at Screening.
- Bilirubin \>1.25 upper limit of normal (ULN) at Screening.
- Absolute neutrophil count \<lower limit of normal (LLN) at Screening.
- Estimated glomerular filtration rate of ≤60 mL/min for women and men (based on the Chronic Kidney Disease Epidemiology Collaboration equation) at the Screening.
- Fasting low-density lipoprotein ≥160 mg/dL at Screening.
- Hemoglobin \<LLN at Screening.
- Platelet count \<LLN at Screening.
- 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
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Miami, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Miami, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.