Study to Evaluate the Effect on Obesity of QW Nimacimab and QW Nimacimab Co-administered With Semaglutide vs Placebo

Part of paid clinical trials in Anniston, Alabama.

Sponsor
Skye Bioscience, Inc.
Study ID
NCT06577090
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Nimacimab injection — BIOLOGICAL
    Nimacimab injection 200 mg
  • Nimacimab placebo injection — BIOLOGICAL
    matching nimacimab placebo injection
  • semaglutide injection — COMBINATION_PRODUCT
    semaglutide injection 0.25 mg, 0.5 mg, 1 mg, 1.7 mg, 2.4 mg + nimacimab 200 mg
  • Nimacimab 300 mg injection — BIOLOGICAL
    Nimacimab injection 300 mg

Study Details

This is a proof-of-concept study to assess the safety and efficacy of Nimacimab Injection compared to an active and placebo injection control.

Key Dates

Start date
Aug 22, 2024
Status verified
Jan 2026
Primary completion
Nov 20, 2026
Completion
Feb 28, 2027

Study Design

Enrollment
136 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Nimacimab injection
    Nimacimab injection 200 mg
  • Placebo Comparator: Nimacimab placebo injection
    Matching nimacimab placebo injection
  • Experimental: Semaglutide injection + Nimacimab injection 200 mg
    Semaglutide injection administered according to dose escalation described in semaglutide prescribing information plus concomitant administration of Nimacimab Injection 200 mg
  • Active Comparator: Semaglutide injection + Nimacimab placebo injection
    Semaglutide injection administered according to dose escalation described in semaglutide Prescribing Information plus concomitant administration of Nimacimab Injection or matching placebo injection
  • Experimental: Open-label 300 mg Nimacimab injection (study extension)
    Weekly nimacimab injection 300 mg open-label (study extension)

Primary Outcome Measure

Percent change in body weight (main study) [ Time Frame: From Baseline to Week 26 ]

Locations (16)

FacilityCityStateZIPSite coordinators
Pinnacle Research GroupAnnistonAlabama36207-
Diablo Clinical Research, Inc.Walnut CreekCalifornia94598-
Chase Medical Research, LLCWaterburyConnecticut06708-
ACCEL Research SitesAtlantaGeorgia30342-
Center for Advanced Research & EducationGainesvilleGeorgia30501-
L-MARC Research CenterLouisvilleKentucky40213-
Be Well Clinical StudiesLincolnNebraska68516-
Palm Research CenterLas VegasNevada89148-
ActivMed Practices & ResearchPortsmouthNew Hampshire03801-
Weill Cornell MedicineNew YorkNew York11375-
Accellacare of WilmingtonWilmingtonNorth Carolina28401-
Lillestol Research, LLCFargoNorth Dakota58104-
Velocity Clinical Research, DallasDallasTexas75230-
Be Well Clinical StudiesRound RockTexas78681-
Charlottesville Medical ResearchCharlottesvilleVirginia22911-
Rainier Clinical Research CenterRentonWashington98057-

Find similar trials in Anniston, AL

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Pinnacle Research Group· Anniston, ALDiablo Clinical Research, Inc.· Walnut Creek, CAChase Medical Research, LLC· Waterbury, CTACCEL Research Sites· Atlanta, GACenter for Advanced Research & Education· Gainesville, GAL-MARC Research Center· Louisville, KY

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