Ignite Creation Date:
2025-12-25 @ 4:28 AM
Ignite Modification Date:
2025-12-26 @ 3:32 AM
Study NCT ID:
NCT06252220
Status:
RECRUITING
Last Update Posted:
2025-05-21
First Post:
2024-01-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
First in Human Study in Subjects With Obesity, But Otherwise Healthy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Masking is to be done at the pharmacy level. The pharmacists that do not have other responsibilities in the study will prepare and administer the drug.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 81}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-20', 'studyFirstSubmitDate': '2024-01-09', 'studyFirstSubmitQcDate': '2024-02-07', 'lastUpdatePostDateStruct': {'date': '2025-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with treatment-related adverse events as assessed by CTCAE v4.0', 'timeFrame': 'From date of randomization (baseline) until the discontinuation or completion, whichever came first, assessed up to 26 Days for Part 1 and 47 Days for Part 2.', 'description': 'AEs, SAEs, TEAEs and AEs leading to treatment discontinuation.'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetic', 'timeFrame': 'From date of randomization (baseline) until the discontinuation or completion, whichever came first, assessed up to 26 Days for Part 1 and 47 Days for Part 2.', 'description': 'PK profile of DA-1726 serum concentrations of DA-1726 over time.'}, {'measure': 'Immunogenicity', 'timeFrame': 'From date of randomization (baseline) until the discontinuation or completion, whichever came first, assessed up to 26 Days for Part 1 and 47 Days for Part 2.', 'description': 'Measurement of anti-drug antibodies and neutralizing antibodies at baseline and at identified points during the study.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Willing and able to provide informed consent prior to initiation of any study specific procedures/activities.\n2. Males and females ≥18 to \\<=65 years of age, at the time of signing informed consent, who have been diagnosed with obesity, or have signs/symptoms consistent with obesity.\n3. Except for obesity, otherwise healthy as determined by the investigator based on a medical evaluation including physical exam, medical history, laboratory tests, and ECGs.\n4. Body mass index (BMI) ≥ 30 kg/m2 to 45 kg/m2 (Obesity to be confirmed by Caliper test).\n5. Has maintained a stable body weight during the 3 months prior to Screening (\\<5% body weight change).\n6. Willing to maintain current diet and physical activity regimen.\n\n * SAD Cohorts (Be willing to eat a standard diet while in the Clinical Research Unit).\n * 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.\n7. Females must be of non-reproductive potential:\n\n * Postmenopausal defined as:\n\n * Age of ≥55 years with no menses for at least 12 months; OR\n * 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\n * History of hysterectomy; OR\n * History of bilateral oophorectomy\n * History of tubal ligation (surgically sterile)\n8. 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.\n\nAcceptable methods of birth control include:\n\n* Sexual abstinence\n* Vasectomy and testing that shows there are no sperm in semen.\n* Condom with spermicide (male) in combination with barrier methods (diaphragm, cervical cap, or cervical sponge), hormonal birth control, or IUS (females)\n\nExclusion Criteria:\n\n1. History or clinical evidence of diabetes mellitus, including a fasting glucose of ≥ 120 mg/dL and/or HbA1c ≥ 6.5% at Screening.\n2. Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2).\n3. History of cholecystectomy \\< 6 months prior to screening.\n4. Subjects with screening calcitonin level of ≥15 pg/mL (calcitonin levels will be monitored during the study).\n5. Triglycerides ≥500 mg/dL at Screening.\n6. History of pancreatitis.\n7. Have a medical history or current evidence of clinically significant cardiac condition as evidenced by any of the following at Screening :\n\n * QTc at Screening from locally generated data of \\>450 msec in males or \\>470 msec in females or history of long QT syndrome\n * Supine systolic BP higher than 150 mmHg and a supine diastolic BP higher than 95 mmHg at Screening or check-in\n * Supine HR of \\<50 or \\>100 beats per minute on 2 of 3 triplicate ECGs at Screening or check-in\n * Heart block of the 1st, 2nd, or 3rd degree\n * Sick sinus syndrome (irregular heartbeat patterns)\n * Disorders in cardiac conduction\n * Peripheral blood circulation issues\n * Heart valve conditions\n * Cardiomyopathy\n * History of myocardial infarction\n * Unstable angina\n * History of heart artery bypass surgery\n * History of stroke\n * History of heart failure\n8. Regular consumption of caffeine-containing beverages, including coffee, tea, energy drinks, and caffeinated sodas, exceeding 3 cups per day.\n9. Current use of tobacco products or having a history of tobacco use within the past 6 months.\n10. 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.\n11. 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).\n12. 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).\n13. Untreated or uncontrolled hypo/hyperthyroidism defined as thyroid-stimulating hormone \\>6 mIU/L or \\<0.4 mIU/L.\n14. Obesity that was induced by other endocrinologic disorders (e.g., Cushing\'s Syndrome).\n15. Evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies.\n16. Evidence of hepatitis C and/or positive hepatitis C antibody and hepatitis B, hepatitis B core antibody, and/or positive hepatitis B surface antigen.\n17. 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.\n18. Any lifetime history of a suicidal attempt or any suicidal behavior, as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS).\n19. History of malignancy of any type, other than basal cell carcinoma, occurring less than 5 years prior to randomization.\n20. 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.\n21. Previous surgical treatment for obesity or any form of bariatric surgery.\n22. 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.\n23. 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.\n24. Have received any vaccine ≤30 days prior to check-in.\n25. Albumin level \\<3.5 g/dL (\\<35 g/L) at Screening.\n26. Aspartate aminotransferase (AST) ≥1.25 × upper limit of normal (ULN) at Screening.\n27. Alanine aminotransferase (ALT) ≥1.25 × upper limit of normal (ULN) at Screening.\n28. Bilirubin \\>1.25 upper limit of normal (ULN) at Screening.\n29. Absolute neutrophil count \\<lower limit of normal (LLN) at Screening.\n30. Estimated glomerular filtration rate of ≤60 mL/min for women and men (based on the Chronic Kidney Disease Epidemiology Collaboration equation) at the Screening.\n31. Fasting low-density lipoprotein ≥160 mg/dL at Screening.\n32. Hemoglobin \\<LLN at Screening.\n33. Platelet count \\<LLN at Screening.\n34. Current or history of treatment with medications that may cause significant weight gain, within 3 months of Screening, including:\n\n * Systemic corticosteroids (except for a short course of treatment, i.e., 7-10 days)\n * Tricyclic antidepressants\n * Atypical antipsychotics\n * Mood stabilizers (e.g., imipramine, amitriptyline, mirtazapine, paroxetine, phenelzine, chlorpromazine, thioridazine, clozapine, olanzapine, valproic acid and its derivatives, and lithium)\n * Antidiabetic Medications (e.g., insulin or certain sulfonylureas, that may lead to weight gain)\n * Beta-blockers (e.g., the ones used to treat conditions like hypertension that may cause weight gain)\n * Antihistamines (particularly the first-generation ones, that may have sedative effects and could potentially contribute to weight gain)\n * Contraceptives\n * Any non-steroidal anti-inflammatory drugs\n35. 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.'}, 'identificationModule': {'nctId': 'NCT06252220', 'briefTitle': 'First in Human Study in Subjects With Obesity, But Otherwise Healthy', 'organization': {'class': 'INDUSTRY', 'fullName': 'NeuroBo Pharmaceuticals Inc.'}, 'officialTitle': '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.', 'orgStudyIdInfo': {'id': 'DA-1726-1001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Part 1 - Single Ascending Dose', 'description': '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.', 'interventionNames': ['Drug: DA-1726', 'Drug: Placebo to DA-1726']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part 2 - Multiple Ascending Dose', 'description': '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.', 'interventionNames': ['Drug: DA-1726', 'Drug: Placebo to DA-1726']}], 'interventions': [{'name': 'DA-1726', 'type': 'DRUG', 'description': 'Active', 'armGroupLabels': ['Part 1 - Single Ascending Dose', 'Part 2 - Multiple Ascending Dose']}, {'name': 'Placebo to DA-1726', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Part 1 - Single Ascending Dose', 'Part 2 - Multiple Ascending Dose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33014', 'city': 'Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Alexander N Prezioso, MD', 'role': 'CONTACT', 'email': 'aprezioso@ergclinical.com', 'phone': '201-320-6446'}], 'facility': 'Clinical Pharmacology of Miami, LLC', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'centralContacts': [{'name': 'Robert Homolka, MS', 'role': 'CONTACT', 'email': 'CRinfo@MetaViaTx.com', 'phone': '8572991038'}, {'name': 'Ji Eun Lee, PharmD', 'role': 'CONTACT', 'email': 'CRInfo@MetaViaTx.com', 'phone': '8572991038'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NeuroBo Pharmaceuticals Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}