Investigating the Effect of Obicetrapib on Lipoprotein Metabolism

NCT05972278 | Active Not Recruiting Phase 1 FDA Drug

• 2 other identifiers: TA-8995-204The NICE Study
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the treatment effect with obicetrapib (10 mg) on the fractional catabolic rate (FCR) of apolipoprotein (apo) B100 in low-density lipoprotein (LDL).

Conditions

Lipid Metabolism

Outcome Measures

Primary Outcomes (1)

• Treatment with obicetrapib (10 mg) on the fractional catabolic rate (FCR) of apolipoprotein (apo) B100 in low-density lipoprotein (LDL).

  The mean differences (obicetrapib - placebo) in the LDL apoB100 FCR using the baseline measure (no study treatment) compared to the LDL apoB100 FCR of each variable following the Treatment Period.

  8-12 week

Secondary Outcomes (1)

• Treatment with obicetrapib (10 mg) on the production rate (PR) of apolipoprotein(a), or apo(a), in Lp(a).

  8-12 weeks

Other Outcomes (1)

• Treatment with obicetrapib (10 mg) on the FCR of total apolipoprotein (apo) B100 in plasma.

  8-12 weeks

Study Arms (2)

Obicetrapib placebo

PLACEBO COMPARATOR

identical matching placebo

Drug: Obicetrapib

Obicetrapib 10 mg

EXPERIMENTAL

10 mg tablets

Drug: Obicetrapib

Interventions

Obicetrapib DRUG

1 tablet daily

Also known as: tablets

Obicetrapib 10 mg; Obicetrapib placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing to sign the Informed Consent Form.
• Male or female between 18 to 75 years of age.
• Females may be enrolled if they are not pregnant, are not breastfeeding, and do not plan on becoming pregnant during the study.
• Stable weight (± 3 kg) for at least 6 weeks prior to screening.
• Body mass index (BMI) of \> 18.5 and ≤ 40 kg/m2 at Screening. BMI is calculated by taking the participants weight in kg and dividing it by the height in meters, squared.
• Participant is judged to be in good health by the Study PI based on medical history, physical examination, vital sign measurements, electrocardiogram (ECG) assessments, and laboratory safety tests performed at Screening and/or prior to administration of the initial dose of study drug.
• Fasting plasma triglyceride level ≤ 400 mg/dL at Screening.
• LDL-C level of ≥ 100 mg/dL and ≤ 190 mg/dL at Screening.

You may not qualify if:

• Has taken or plans to take any lipid-lowering medications or medications known to alter lipoprotein metabolism within 4 weeks of Screening, (e.g. statins, fibrates, niacin, cholesterol absorption inhibitors, bile acid-sequestrants, fish oils, PCSK9 inhibitors, red yeast rice, glucocorticoids, and anabolic agents).
• Current, or any previous history of New York Heart Association (NYHA) class III or IV heart failure or left ventricular ejection fraction \< 30%.
• HDL-C \> 60 mg/dL if male or \>70 mg/dL if female, at Screening.
• An eGFR \< 45 mL/min/1.73m2 at the Screening visit or history of end-stage renal disease (ESRD).
• Active liver disease, defined as any known current infectious, neoplastic, or metabolic pathology of the liver; unexplained elevations in alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2 x upper limit of normal (ULN); or total bilirubin \> 2 x ULN at the and/or Screening visit.
• History of stroke, chronic seizures, or major neurological disorder.
• Participants on thyroid hormone replacement treatment at the time of screening, there is no lower thyroid stimulating hormone (TSH) threshold for entry. The subject must have been on a stable dose of thyroid hormone therapy for ≥ 6 weeks prior to the screening. If TSH levels are undetectable and a change in thyroid hormone therapy is recommended, or if this represents a new diagnosis, then the participant is not eligible. Note: Hypothyroidism is defined as having a TSH \> 20% above the local laboratory's upper limit of the normal reference range. One redraw will be allowed if the original TSH value is equal to or less than 40% above the normal reference range at the local laboratory. The participant must meet his criterion upon redraw.
• Participant with a history of neoplastic disease. Note: Participant treated non-melanoma skin carcinoma, and other malignancies which have been successfully treated ≥ 5 years prior to the Screening visit where, in the judgment of both the PI and treating physician, appropriate follow-up has revealed no evidence of recurrence from the time of treatment through the time of the Screening visit.
• Has participated in another investigational drug study within 30 days of Screening

Sponsors & Collaborators

• NewAmsterdam Pharma: lead
• University of Pennsylvania: collaborator

Study Sites (1)

Archna Bajaj, MD

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Interventions

Tablets

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Officials

• Archna Bajaj, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a phase 1, single-site, double-blind, randomized, placebo-controlled, 2 period, fixed-sequence, pharmacodynamic study in healthy participants meeting the eligibility requirements. Participants will be randomized in a 1:1 ratio to either obicetrapib or matching placebo, and evenly distributed between treatment groups based on their Screening Lp(a) values; ≥ 30 mg/dL vs \< 30 mg/dL. LDL-C levels ≥ 100 mg/dL and ≤ 190 mg/dL have been selected for this study as the target population as this is the population of patients targeted for treatment with obicetrapib as an adjunct to statin therapy.

Study Record Dates

• First Submitted: July 25, 2023
• First Posted: August 2, 2023
• Study Start: December 1, 2023
• Primary Completion: September 26, 2024
• Study Completion: October 14, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)