A Study to Evaluate the Effect of Obicetrapib/Ezetimibe 10 mg Fixed-Dose Combination or Obicetrapib 10 mg Daily on Top of Guideline-Recommended Lipid-Lowering Therapy in Participants With Type 2 Diabetes and/or Metabolic Syndrome

Part of paid clinical trials in Sun City West, Arizona.

Sponsor
NewAmsterdam Pharma
Study ID
NCT07219602
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Lipidemia
  • Metabolic Syndrome (MetS)
  • Type 2 Diabetes (T2DM)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

This study will be a placebo-controlled, double-blind, randomized, Phase 3 study to evaluate the efficacy, safety, and tolerability of obicetrapib 10 mg, both as a fixed-dose combination (FDC) with ezetimibe 10 mg and as monotherapy, on top of guideline-recommended lipid-lowering therapy in patients with metabolic syndrome and/or Type 2 Diabetes Mellitus.

Key Dates

Start date
Dec 11, 2025
Status verified
Mar 2026
Primary completion
Mar 31, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Obicetrapib/Ezetimibe
    obicetrapib 10 mg + ezetimibe 10 mg FDC daily
  • Experimental: Obicetrapib
    obicetrapib 10 mg daily
  • Placebo Comparator: Placebo
    Placebo on top of guideline-recommended lipid-lowering therapy
  • Experimental: Open-Label Extension
    Open-Label Extension (OLE) with the FDC of Obicetrapib 10 mg and Ezetimibe 10 mg

Primary Outcome Measure

The percent change from Baseline to Day 84 in LDL-C compared with placebo for the following treatment groups: - obicetrapib 10 mg + ezetimibe 10 mg FDC treatment group; and - obicetrapib 10 mg monotherapy treatment group [ Time Frame: 84 days ]

Central Contacts

Locations (20)

FacilityCityStateZIPSite coordinators
Clinical Research Institute of ArizonaSun City WestArizona85375-
Scripps Health - Whittier Diabetes InstituteLa JollaCalifornia92037-
East Coast Institute of Research LLCJacksonvilleFlorida32216-
UF Health JacksonJacksonvilleFlorida32209-
East Coast Institute of Research LLCLake CityFlorida32055-
Floridian Clinical ResearchMiami LakesFlorida33016-
Louisville Metabolic and Atherosclerosis Research Center (L-MARC)LouisvilleKentucky40213-
MD Medical ResearchOxon HillMaryland20745-
Jefferson City Medical GroupJefferson CityMissouri65109-
Montana Medical ResearchMissoulaMontana59808-
Inspira Health - Internal Medicine AssociatesBridgetonNew Jersey08302-
Central New York Clinical ResearchManliusNew York13104-
Velocity Clinical ResearchDurhamNorth Carolina27710-
Floridian Clinical ResearchGreensboroNorth Carolina27408-
Centricity Research dba Lucas ResearchMorehead CityNorth Carolina28557-
Summit Research GroupMunroe FallsOhio44262-
Juno Research LLC - Medical CenterHoustonTexas77054-
Clinical Trials of Texas dba Flourish ResearchSan AntonioTexas78229-
Burke Internal MedicineBurkeVirginia22015-2234-
Burke International Medicine DBA Manassas Clinical Research CenterManassasVirginia20110-

Find similar trials in Sun City West, AZ

By research site
Clinical Research Institute of Arizona· Sun City West, AZScripps Health - Whittier Diabetes Institute· La Jolla, CAEast Coast Institute of Research LLC· Jacksonville, FLUF Health Jackson· Jacksonville, FLEast Coast Institute of Research LLC· Lake City, FLFloridian Clinical Research· Miami Lakes, FL

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