Lipid MetabolismPhase 1NCT05972278
Investigating the Effect of Obicetrapib on Lipoprotein Metabolism
A Phase 1 study testing Obicetrapib in people with Lipid Metabolism, run by NewAmsterdam Pharma at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Lipid Metabolism
- What is being tested?
- Obicetrapib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2023to 14 Oct 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Placebo-Controlled, Phase 1 Study to Investigate the Effect of Obicetrapib on Lipoprotein Metabolism.
To determine the treatment effect with obicetrapib (10 mg) on the fractional catabolic rate (FCR) of apolipoprotein (apo) B100 in low-density lipoprotein (LDL).
Read the detailed 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.
- Conditions
- Lipid Metabolism
- Being tested
- Obicetrapib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObicetrapibDrug
Also called tablets
1 tablet daily
| Study group | Role | What they receive |
|---|---|---|
| Obicetrapib placebo | Placebo comparator | identical matching placebo Receives: Drug: Obicetrapib |
| Obicetrapib 10 mg | Experimental | 10 mg tablets Receives: Drug: Obicetrapib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
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.
Measured: 8-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start1 Dec 2023
- Primary completion26 Sep 2024 (estimated)
- Study completion14 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lipid MetabolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- NewAmsterdam Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Pennsylvania
- Responsible party
- Sponsor
- Investigators
- Archna Bajaj, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05972278
- Sponsor's protocol ID
- TA-8995-204
- Other IDs
- The NICE Study
- Status last verified
- Sep 2024
- First submitted
- 25 Jul 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo-Controlled, Phase 1 Study to Investigate the Effect of Obicetrapib on Lipoprotein Metabolism.
- ClinicalTrials.gov ID
- NCT05972278
- Acronym / sponsor ID
- TA-8995-204
- Conditions
- Lipid Metabolism
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (actual)
- Lead sponsor
- NewAmsterdam PharmaIndustry (pharma, biotech, devices)
- Collaborators
- University of Pennsylvania
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 26 Sep 2024 (estimated)
- Study completion
- 14 Oct 2024 (estimated)
- First posted
- 2 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the treatment effect with obicetrapib (10 mg) on the fractional catabolic rate (FCR) of apolipoprotein (apo) B100 in low-density lipoprotein (LDL).
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Obicetrapib placebo | Placebo comparator | Drug: Obicetrapibidentical matching placebo |
| Obicetrapib 10 mg | Experimental | Drug: Obicetrapib10 mg tablets |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (10 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObicetrapibAlso: tablets1 tablet daily | Drug | Obicetrapib 10 mg, Obicetrapib placebo |
Primary outcome
Treatment with obicetrapib (10 mg) on the fractional catabolic rate (FCR) of apolipoprotein (apo) B100 in low-density lipoprotein (LDL).
Time frame: 8-12 week
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.
1 secondary outcome
Treatment with obicetrapib (10 mg) on the production rate (PR) of apolipoprotein(a), or apo(a), in Lp(a).
Time frame: 8-12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Archna Bajaj, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Obicetrapib in people with Lipid Metabolism, run by NewAmsterdam Pharma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment with obicetrapib (10 mg) on the fractional catabolic rate (FCR) of apolipoprotein (apo) B100 in low-density lipoprotein (LDL). (time frame: 8-12 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.