menu

Clinical Trials & Expanded
Access

Open Clinical Trials

Participating in clinical trials of investigational medicines may help contribute to the approval and availability of new treatments for patients in need, as these trials generate comprehensive data that ensures new therapies are both safe and effective. Clinical trials may also help you learn more about your health and take an active role in your treatment journey.

Learn more about actively enrolling obicetrapib trials by going to ClinicalTrials.gov and its online database of clinical studies.

Our Expanded Access Policy

We understand the urgency felt by patients and their families facing a serious or immediately life-threatening disease when there are no standard treatment options available, or all treatment options have been exhausted.

At this time, we are not evaluating requests for compassionate access. In the future, NewAmsterdam may consider providing access to our investigational treatments to patients with a serious or immediately life-threatening disease and to those who are unable to participate in one of our ongoing clinical trials. We want to help as many patients as possible while maintaining our primary focus of moving our investigational therapies through clinical trials, and, ultimately, toward regulatory approvals.

For our investigational treatments that are in later stages of development, we may also consider opening broader expanded access clinical programs. The type of compassionate access or expanded access program can vary from country to country for many reasons, including national and local laws, as well as health authority requirements. This may be the case even for the same investigational treatment. However, all requests for access to our investigational therapies outside of clinical trials must meet all of the below criteria in order to be considered.

Criteria:

  • The patient must have a serious or immediately life-threatening disease for which there are no standard treatment options available or all treatment options have been exhausted
  • The patient must not be eligible for ongoing clinical trials of the investigational medicine or must not be physically able to travel to a clinical trial site
  • The investigational treatment must be in active clinical development for the disease with sufficient clinical data available to suggest that the drug may provide therapeutic benefit for that disease
  • Requests for access to our investigational medicines must be made by a qualified physician who agrees to directly supervise treatment of the patient. The physician making the request must have made a determination that the probable risk to the patient from the investigational treatment is not greater than the probable risk from the disease. We will work with the patient’s physician to provide them with available information about the investigational treatment at the time of the request to enable this assessment. We will acknowledge receipt of these requests within 5 business days
  • Providing the investigational treatment will not compromise or interfere with its clinical development, including the initiation, conduct, or completion of clinical trials
  • There must be a sufficient amount of the investigational treatment available for the requested use after ensuring adequate supply for ongoing and planned clinical trials and other supporting work required for regulatory submissions

Because we believe it is important to have clinical data regarding the potential benefits and risks of an investigational medicine in a particular disease, we are not supporting requests for expanded access to our investigational treatments in diseases that we are not actively studying in clinical trials.

While we cannot guarantee compassionate or expanded access to our investigational treatments, NewAmsterdam will continuously evaluate all of our clinical programs in relation to these criteria and in the future will evaluate all requests individually. Appropriate health authorities, such as the U.S. Food and Drug Administration, the Institutional Review Board, or Ethics Committee at the patient’s treating hospital or clinic must also review and approve the proposed use of the investigational treatment by the patient before NewAmsterdam can provide it. In addition, the submitting physician must agree to comply with regulatory obligations, including obtaining patient informed consent, patient monitoring, and safety reporting.

If you have a question regarding a request for access to one of NewAmsterdam’s investigational therapies that meets the above criteria, please send your inquiry to access@NewAmsterdamPharma.com.

NewAmsterdam reserves the right to revise this expanded access policy at any time. The posting of this policy does not guarantee access to any investigational medicine by any patient.