Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 12:02 PM
Study NCT ID:
NCT07430059
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-24
First Post:
2026-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Tolerability and Pharmacokinetics of a Subcutaneous Semaglutide Implant
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000591245', 'term': 'semaglutide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-17', 'studyFirstSubmitDate': '2026-02-10', 'studyFirstSubmitQcDate': '2026-02-17', 'lastUpdatePostDateStruct': {'date': '2026-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the plasma concentration-time curve (AUC)', 'timeFrame': '4 weeks', 'description': 'total semaglutide concentration'}, {'measure': 'Maximum plasma concentration (Cmax)', 'timeFrame': '4 weeks', 'description': 'Maximal semaglutide concentration'}, {'measure': 'Time to maximum semaglutide concentration (Tmax)', 'timeFrame': '4 weeks', 'description': 'Time to reach maximal semaglutide concentration'}, {'measure': 'Adverse Events', 'timeFrame': '4 weeks', 'description': 'Incidence of treatment-emergent adverse events'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['obesity', 'overweight', 'semaglutide', 'implant', 'glp-1'], 'conditions': ['Obesity & Overweight']}, 'descriptionModule': {'briefSummary': 'The study will evaluate the safety, tolerability and drug levels of a semaglutide implant placed just under the skin for a period of 4 weeks compared to 4 weekly injections of semaglutide (Wegovy) in overweight/obese participants who are otherwise healthy..', 'detailedDescription': 'This open label, randomized, parallel-group study will evaluate participants with a body mass index (BMI) between 27 and 40 kg/m2 (inclusive). Safety, tolerability and PK data will be collected and evaluated for the 4-week treatment period. Participants will undergo a Screening Visit and those who meet eligibility will be randomized (1:1) to one of 2 study groups:\n\n* Group 1: Semaglutide Implant (NPM-139)\n* Group 2: Semaglutide 0.25 mg SC once weekly All participants will be domiciled for at least 48 hours following insertion of the implant (Group 1) or first dose of semaglutide 0.25 mg (Group 2).\n\nSubsequently, participants will return to the clinic weekly until study end. At each of these visits, participants will have blood samples drawn for PK. After sample collections, site staff will administer semaglutide injections to participants in Group 2.\n\nAfter 4 weeks of treatment (end of study), final PK samples will be collected and participants with implants will undergo a brief implant removal procedure under local anesthetic.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI between 27 and 40 kg/m2 (inclusive)\n* HbA1c \\</= 6.0% and FPG \\</+ 6.7 mmil/L\n* eGFR \\>/= 60 mL/m2\n* No significant health issues in the opinion of the Investigator that would preclude study participation, as determined by medical history and physical examination\n\nExclusion Criteria:\n\n* Type 1 or Type 2 Diabetesa\n* A clinically significant medical condition that could potentially affect study participation and/or personal well-being, as judged by the Investigator\n* Treatment with glucose lowering agent(s) within 3 months before Screening'}, 'identificationModule': {'nctId': 'NCT07430059', 'acronym': 'SLIM-1', 'briefTitle': 'Safety, Tolerability and Pharmacokinetics of a Subcutaneous Semaglutide Implant', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vivani Medical, Inc'}, 'officialTitle': 'A Randomized, Parallel-Group Study to Assess the Safety, Tolerability, and Pharmacokinetics of Semaglutide Implant', 'orgStudyIdInfo': {'id': 'VANI-NP-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Semaglutide Implant (NPM-139)', 'description': 'Each participants in this arm will receive one Semaglutide Implant (NPM-139) which will be inserted subcutaneously in the upper outer arm and subsequently removed after 4 weeks of treatment.', 'interventionNames': ['Combination Product: Semaglutide Implant (NPM-139)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Semaglutide (Wegovy) weekly injection', 'description': 'Each participant in this arm will receive Semaglutide (Wegovy) 0.25 mg subcutaneous injection weekly for 4 weeks of treatment.', 'interventionNames': ['Drug: Semaglutide (Wegovy) weekly injection']}], 'interventions': [{'name': 'Semaglutide Implant (NPM-139)', 'type': 'COMBINATION_PRODUCT', 'description': 'Semaglutide Implant (NPM-139) is a drug/device combination product consisting of a subdermal titanium implant \\~23 mm long and 2 mm in diameter, containing a sterile liquid formulation of semaglutide that is released from the implant at a substantially constant rate over at least 15 weeks.', 'armGroupLabels': ['Semaglutide Implant (NPM-139)']}, {'name': 'Semaglutide (Wegovy) weekly injection', 'type': 'DRUG', 'description': 'Semaglutide (Wegovy) is a clear, colorless solution provided as Wegovy FlexTouch four-dose pens: 0.25 mg/0.5 mL. It is injected SC in the abdomen, thigh or upper arm once/week.', 'armGroupLabels': ['Semaglutide (Wegovy) weekly injection']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Chief Medical Officer, MD', 'role': 'CONTACT', 'email': 'clinical@vivanai.com', 'phone': '4155068462'}], 'overallOfficials': [{'name': 'Lisa Porter, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Vivani Medical, Inc'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vivani Medical, Inc', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Avance Clinical Pty Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}