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Semaglutide

Phase 1

Obesity & Overweight | Small molecule | Metabolic |Vivani Medical, Inc.|Last Updated: Feb 24, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment20
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07430059Safety, Tolerability and Pharmacokinetics of a Subcutaneous Semaglutide ImplantPHASE1 NOT YET_RECRUITING 20Apr 1, 2026Sep 1, 2026Feb 24, 2026 -
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Study Endpoints
Primary Endpoints
Area under the plasma concentration-time curve (AUC)
4 weeks

total semaglutide concentration

Maximum plasma concentration (Cmax)
4 weeks

Maximal semaglutide concentration

Time to maximum semaglutide concentration (Tmax)
4 weeks

Time to reach maximal semaglutide concentration

Adverse Events
4 weeks

Incidence of treatment-emergent adverse events

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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Semaglutide Implant (NPM-139)EXPERIMENTALEach 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.
Semaglutide (Wegovy) weekly injectionACTIVE_COMPARATOREach participant in this arm will receive Semaglutide (Wegovy) 0.25 mg subcutaneous injection weekly for 4 weeks of treatment.
Interventions
NameTypeDescription
Semaglutide Implant (NPM-139)COMBINATION_PRODUCTSemaglutide 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.
Semaglutide (Wegovy) weekly injectionDRUGSemaglutide (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.
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Eligibility Criteria
Age Range18 Years — 60 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * BMI between 27 and 40 kg/m2 (inclusive) * HbA1c \</= 6.0% and FPG \</+ 6.7 mmil/L * eGFR \>/= 60 mL/m2 * No significant health issues in the opinion of the Investigator that would preclude study participation, as determined by medical history and physical examination Exclusio...

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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07430059primaryCompletionDate: changed
LOWMay 24, 2026NCT07430059studyFirstPostDate: changed