Investigating the Effect of Obicetrapib on Lipoprotein Metabolism

Lipid Metabolism Clinical Trial

Official title:

A Placebo-Controlled, Phase 1 Study to Investigate the Effect of Obicetrapib on Lipoprotein Metabolism.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05972278
• Other study ID #: TA-8995-204
• Secondary ID: The NICE Study
• Status: Recruiting
• Phase: Phase 1
• Start date: December 1, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: January 2024
• Source: NewAmsterdam Pharma
• Contact: Archna Bajaj, MD
• Phone: +1 215-662-7197
• Email: abajaj[@]pennmedicine.upenn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

The study population will comprise 20 adults, 18 to 75 years of age, with LDL-C level ≥ 100 and ≤ 190 mg/dL, and in generally good health.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 30, 2024
• Est. primary completion date: October 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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%.

• Uncontrolled hypertension defined as either systolic blood pressure = 180 mmHg or diastolic blood pressure = 100 mmHg prior to the Baseline visit, taken as the average of triplicate measurements. One triplicate retest will be allowed during the same visit, at which point if the retest result is no longer exclusionary, the participant may be randomized.

• 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

Related Conditions & MeSH terms

• Lipid Metabolism

Intervention

Drug:
• Obicetrapib
1 tablet daily

Locations

Country	Name	City	State
United States	Archna Bajaj, MD	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
NewAmsterdam Pharma	University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Treatment with obicetrapib (10 mg) on the FCR of total apolipoprotein (apo) B100 in plasma.	The mean difference (obicetrapib - placebo) on the FCR of total apolipoprotein (apo) B100 in plasma using the baseline measure (no treatment) compared to the FCR of apoliprotien (apo) B100 following the Treatment Period.	8-12 weeks
Primary	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	Treatment with obicetrapib (10 mg) on the production rate (PR) of apolipoprotein(a), or apo(a), in Lp(a).	The mean differences (obicetrapib - placebo) in the apo(a) in Lp(a) production rate using the baseline measure (no treatment) compared to the apo(a) PR obtained following the Treatment Period.	8-12 weeks