ObesityPhase 1NCT06252220
First in Human Study in Subjects With Obesity, But Otherwise Healthy
A Phase 1 study testing DA-1726 in people with Obesity, run by NeuroBo Pharmaceuticals Inc. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- DA-1726
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 139 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Mar 2024to 9 Nov 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to 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 tests, and ECGs.
- 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.
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- 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 <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.
- 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)
Who cannot join
- 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.
- Subjects 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.
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- 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
- 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 interfering with the interpretation of data.
- 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).
- 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, phentermine, naltrexone, lorcaserin, liraglutide, semaglutide, tirzepatide or metformin.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Clinical Pharmacology of Miami, LLC
Miami, Florida, 33172
Alexander N Prezioso, MD, 201-320-6446, aprezioso@ergclinical.com
About this study
Official title: A Phase 1, Randomized, Placebo-Controlled, Double-Blind First in Human, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DA-1726 in Participants With Obesity.
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.
Read the detailed description
This is a Phase 1, randomized, placebo-controlled, double-blind, sequential parallel group study to investigate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple ascending doses of DA-1726 in adult participants (aged 18 to 65 years) with obesity (BMI ≥30 - 45 kg/m2). DA-1726 will be administered via subcutaneous (SC) injection within the clinic setting.
- Conditions
- Obesity
- Being tested
- DA-1726, Placebo to DA-1726
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DA-1726Drug
Active
Placebo to DA-1726Drug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Part 1 - Single Ascending Dose | Active comparator | Single doses of DA-1726 in adult participants (aged 18 to 65 years) with obesity (BMI ≥30 - 45 kg/m2). DA-1726 will be administered via subcutaneous (SC) injection within the clinic setting. Receives: Drug: DA-1726; Drug: Placebo to DA-1726 |
| Part 2 - Multiple Ascending Dose | Placebo comparator | Multiple doses of DA-1726 in adult participants (aged 18 to 65 years) with obesity (BMI ≥30 - 45 kg/m2). DA-1726 will be administered via subcutaneous (SC) injection within the clinic setting. Receives: Drug: DA-1726; Drug: Placebo to DA-1726 |
| Part 3 - Titration | Active comparator | Multiple doses of DA-1726 in adult participants (aged 18 to 65 years) with obesity (BMI ≥30 - 45 kg/m2). DA-1726 will be administered via subcutaneous (SC) injection within the clinic setting, using either 1-step or 2-steps titration. Receives: Drug: DA-1726; Drug: Placebo to DA-1726 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
AEs, SAEs, TEAEs and AEs leading to treatment discontinuation.
Measured: From date of randomization (baseline) until the discontinuation (up to 24 weeks post-dose baseline)
Secondary outcomes (3)
Pharmacokinetic
PK profile of DA-1726 serum concentrations of DA-1726 over time.
Measured: From date of randomization (baseline) until the study discontinuation (up to 24 weeks post-dose baseline)
Immunogenicity
Measurement of anti-drug antibodies and neutralizing antibodies at baseline until the end of the study (up to 24 weeks post-dose baseline).
Measured: From date of randomization (baseline) until the end of the study (up to 24 weeks post-dose baseline)
Pharmacodynamics
Effect of DA-1726 on body composition, cardiac parameters, renal function, liver function and composition, energy expenditure, dietary changes, lipid, metabolic and proteomic-based biomarkers in participants with obesity.
Measured: From date of randomization (baseline) until the discontinuation (up to 24 weeks post-dose baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start25 Mar 2024
- Primary completion9 Nov 2026 (estimated)
- Study completion9 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 139 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NeuroBo Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Homolka, MS, Study director, MetaVia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06252220
- Sponsor's protocol ID
- DA-1726-1001
- Status last verified
- Apr 2026
- First submitted
- 9 Jan 2024
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Placebo-Controlled, Double-Blind First in Human, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DA-1726 in Participants With Obesity.
- ClinicalTrials.gov ID
- NCT06252220
- Acronym / sponsor ID
- DA-1726-1001
- Conditions
- Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 139 participants (estimated)
- Lead sponsor
- NeuroBo Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Mar 2024 (actual)
- Primary completion
- 9 Nov 2026 (estimated)
- Study completion
- 9 Nov 2026 (estimated)
- First posted
- 9 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a Phase 1, randomized, placebo-controlled, double-blind, sequential parallel group study to investigate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple ascending doses of DA-1726 in adult participants (aged 18 to 65 years) with obesity (BMI ≥30 - 45 kg/m2). DA-1726 will be administered via subcutaneous (SC) injection within the clinic setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1 - Single Ascending Dose | Active comparator | Drug: DA-1726, Drug: Placebo to DA-1726Single doses of DA-1726 in adult participants (aged 18 to 65 years) with obesity (BMI ≥30 - 45 kg/m2). DA-1726 will be administered via subcutaneous (SC) injection within the clinic setting. |
| Part 2 - Multiple Ascending Dose | Placebo comparator | Drug: DA-1726, Drug: Placebo to DA-1726Multiple doses of DA-1726 in adult participants (aged 18 to 65 years) with obesity (BMI ≥30 - 45 kg/m2). DA-1726 will be administered via subcutaneous (SC) injection within the clinic setting. |
| Part 3 - Titration | Active comparator | Drug: DA-1726, Drug: Placebo to DA-1726Multiple doses of DA-1726 in adult participants (aged 18 to 65 years) with obesity (BMI ≥30 - 45 kg/m2). DA-1726 will be administered via subcutaneous (SC) injection within the clinic setting, using either 1-step or 2-steps titration. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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 tests, and ECGs.
- 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).
Key exclusion criteria (58 listed)
- 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.
- Subjects with screening calcitonin level of ≥15 pg/mL (calcitonin levels will be monitored during the study).
- Triglycerides ≥500 mg/dL at Screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DA-1726Active | Drug | Part 1 - Single Ascending Dose, Part 2 - Multiple Ascending Dose, Part 3 - Titration |
| Placebo to DA-1726Placebo | Drug | Part 1 - Single Ascending Dose, Part 2 - Multiple Ascending Dose, Part 3 - Titration |
Primary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: From date of randomization (baseline) until the discontinuation (up to 24 weeks post-dose baseline)
AEs, SAEs, TEAEs and AEs leading to treatment discontinuation.
3 secondary outcomes
Pharmacokinetic
Time frame: From date of randomization (baseline) until the study discontinuation (up to 24 weeks post-dose baseline)
Immunogenicity
Time frame: From date of randomization (baseline) until the end of the study (up to 24 weeks post-dose baseline)
Pharmacodynamics
Time frame: From date of randomization (baseline) until the discontinuation (up to 24 weeks post-dose baseline)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robert Homolka, MS study director
MetaVia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DA-1726 in people with Obesity, run by NeuroBo Pharmaceuticals Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 58 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Robert Homolka, MS (8572991038, CRinfo@MetaViaTx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 (time frame: From date of randomization (baseline) until the discontinuation (up to 24 weeks post-dose baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.