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

NCT07219602 | Recruiting Phase 3 FDA Drug

• 1 other identifier: OBEZ-303
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 20

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

  84 days

Secondary Outcomes (10)

• Percent change from Baseline to Day 84 in non-HDL-C for the obicetrapib 10 mg + ezetimibe 10 mg FDC treatment group compared with the placebo group

  Day 84

• Percent change from Baseline to Day 84 in HDL-C for the obicetrapib 10 mg + ezetimibe 10 mg FDC treatment group compared with the placebo group

  84 days

• Percent change from Baseline to Day 84 in ApoB for the obicetrapib 10 mg + ezetimibe 10 mg FDC treatment group compared with the placebo group

  84 days

• Percent change from Baseline to Day 84 in ApoA1 for the obicetrapib 10 mg + ezetimibe 10 mg FDC treatment group compared with the placebo group

  84 days

• Percent change from Baseline to Day 84 in non-HDL-C for the obicetrapib 10 mg monotherapy treatment group compared with the placebo group;

  84 days

Other Outcomes (8)

• Percent change from Baseline over time in LDL-C

  40 weeks

• Proportion of participants that achieve LDL-C <100 mg/dL (<2.6 mmol/L), LDL-C <70 mg/dL (<1.8 mmol/L), and LDL-C <55 mg/dL (<1.4 mmol/L)

  40 weeks

• Percent change from Baseline over time in non-HDL-C

  40 weeks

Study Arms (4)

Obicetrapib/Ezetimibe

EXPERIMENTAL

obicetrapib 10 mg + ezetimibe 10 mg FDC daily

Drug: obicetrapib 10 mg + ezetimibe 10 mg FDC daily

Obicetrapib

EXPERIMENTAL

obicetrapib 10 mg daily

Drug: Obicetrapib 10 mg

Placebo

PLACEBO COMPARATOR

Placebo on top of guideline-recommended lipid-lowering therapy

Other: Placebo

Open-Label Extension

EXPERIMENTAL

Open-Label Extension (OLE) with the FDC of Obicetrapib 10 mg and Ezetimibe 10 mg

Drug: obicetrapib 10 mg + ezetimibe 10 mg FDC daily

Interventions

obicetrapib 10 mg + ezetimibe 10 mg FDC daily DRUG

FDC

Obicetrapib/Ezetimibe; Open-Label Extension

Obicetrapib 10 mg DRUG

monotherapy

Obicetrapib

Placebo OTHER

placebo on top of guideline-recommended lipid modifying therapy

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• fasting serum LDL-C ≥ 70 mg/dL (≥1.81 mmol/L)
• Have fasting TG ≥150 mg/dL (≥1.7 mmol/L) and \<400 mg/dL (\<4.5 mmol/L)
• Know diagnosis of T2DM OR have metabolic syndrome defined as fasting TG ≥150 mg/dL (≥1.7mmol/L) and \<400 mg/dL (\<4.5 mmol/L) and at least 2 risk factors
• Are on stable guideline-recommended lipid-lowering therapy
• Estimated glomerular filtration rate ≥15 mL/min/1.73 m2

You may not qualify if:

• Have current or any previous history of New York Heart Association class III or IV heart failure or left ventricular ejection fraction \<30%
• Have been hospitalized for heart failure within 5 years prior to Screening
• Have uncontrolled severe hypertension
• Have a formal diagnosis of homozygous familial hypercholesterolemia
• HbA1c ≥10.0% (≥0.100 hemoglobin fraction) or a fasting glucose ≥270 mg/dL (≥15.0 mmol/L) at Screening
• active liver disease

Sponsors & Collaborators

• NewAmsterdam Pharma: lead

Study Sites (20)

Clinical Research Institute of Arizona

Sun City West, Arizona, 85375, United States

RECRUITING

Scripps Health - Whittier Diabetes Institute

La Jolla, California, 92037, United States

RECRUITING

UF Health Jackson

Jacksonville, Florida, 32209, United States

RECRUITING

East Coast Institute of Research LLC

Jacksonville, Florida, 32216, United States

RECRUITING

East Coast Institute of Research LLC

Lake City, Florida, 32055, United States

RECRUITING

Floridian Clinical Research

Miami Lakes, Florida, 33016, United States

RECRUITING

Louisville Metabolic and Atherosclerosis Research Center (L-MARC)

Louisville, Kentucky, 40213, United States

RECRUITING

MD Medical Research

Oxon Hill, Maryland, 20745, United States

RECRUITING

Jefferson City Medical Group

Jefferson City, Missouri, 65109, United States

RECRUITING

Montana Medical Research

Missoula, Montana, 59808, United States

RECRUITING

Inspira Health - Internal Medicine Associates

Bridgeton, New Jersey, 08302, United States

RECRUITING

Central New York Clinical Research

Manlius, New York, 13104, United States

RECRUITING

Velocity Clinical Research

Durham, North Carolina, 27710, United States

RECRUITING

Floridian Clinical Research

Greensboro, North Carolina, 27408, United States

RECRUITING

Centricity Research dba Lucas Research

Morehead City, North Carolina, 28557, United States

RECRUITING

Summit Research Group

Munroe Falls, Ohio, 44262, United States

RECRUITING

Juno Research LLC - Medical Center

Houston, Texas, 77054, United States

RECRUITING

Clinical Trials of Texas dba Flourish Research

San Antonio, Texas, 78229, United States

RECRUITING

Burke Internal Medicine

Burke, Virginia, 22015-2234, United States

RECRUITING

Burke International Medicine DBA Manassas Clinical Research Center

Manassas, Virginia, 20110, United States

RECRUITING

MeSH Terms

Conditions

Hyperlipidemias; Diabetes Mellitus, Type 2; Metabolic Syndrome

Interventions

Ezetimibe

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Endocrine System Diseases; Insulin Resistance; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Azetidines; Azetines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Gagandeep Dhillon

CONTACT

519-209-2341; Gagandeep.dhillon@fortrea.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This protocol includes a 12-week, 3-arm, placebo-controlled, double-blind treatment section, followed by a 40-week open-label extension period. All patients receive the FDC of obicetrapib 10mg and ezetimibe 10 mg, regardless of the intervention received in the double-blind treatment section of this trial.

Study Record Dates

• First Submitted: October 20, 2025
• First Posted: October 22, 2025
• Study Start: December 11, 2025
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

US (20)