Updated May 2026 · ClinicalTrials.gov
Phase 3 Hyperlipidemia Trials
9 Phase 3 trials for Hyperlipidemia, the final stage before a treatment can be submitted for FDA approval.
9 Phase 3 clinical trials for Hyperlipidemia are registered on ClinicalTrials.gov. Phase 3 is the final stage of testing before a treatment can be submitted for FDA approval, and the trials below come directly from the federal registry. Always talk to your doctor before contacting a study site.
What Phase 3 Means for Hyperlipidemia
Phase 3 trials are the largest and most expensive stage of clinical research before potential FDA approval. For Hyperlipidemia, a Phase 3 protocol typically enrolls several hundred to several thousand patients across many medical centers, randomizes participants between the investigational treatment and either a placebo or current standard of care (where ethically appropriate), and tracks them for months or years to confirm that the treatment is both effective and safe in a real-world patient population.
9 Phase 3 trials for Hyperlipidemia are listed on ClinicalTrials.gov. Smaller late-stage pipelines often correspond to rare conditions, niche subpopulations, or treatment areas where Phase 2 results are still being read out.
Novartis Pharmaceuticals (3), Arrowhead Pharmaceuticals (2), Innovent Biologics (Suzhou) Co. Ltd. (1) lead the Phase 3 Hyperlipidemia sponsor list. The blend of industry, academic, and government sponsors on a condition's Phase 3 list is a useful signal of how broadly the research community is engaged with the disease.
Phase 3 Hyperlipidemia Trials on ClinicalTrials.gov
Study to Evaluate Safety, Tolerability and Efficacy of Inclisiran in Children With Homozygous Familial...
This is a pivotal phase III study designed to evaluate safety, tolerability, and efficacy of inclisiran in children (aged 2 to \<12 years) with homozygous familial...
IBI306 Monotherapy in Non-Familial Hypercholesterolemia and Mixed Hyperlipidemia
This is a multi-center, randomized, double-blind, placebo-controlled phase III clinical study evaluating the efficacy and safety of IBI306 monotherapy in Chinese Paricipants with...
Long-Term Safety and Efficacy of Plozasiran in Adults With Hypertriglyceridemia
This is an open-label study to be conducted in adults with hypertriglyceridemia (HTG) and severe hypertriglyceridemia (SHTG). Each participant must have completed all required...
A Clinical Study of Enlicitide in Participants With High Cholesterol (MK-0616-037)
Researchers designed a study medicine called enlicitide to lower low-density lipoprotein cholesterol (LDL-C). In this study, researchers want to learn about giving enlicitide with...
A Study to Evaluate the Safety, Efficacy of SYH2053 as Monotherapy in Chinese Participants With Non-familial...
The purpose of this study is to evaluate the efficacy and safety of SYH2053 monotherapy in patients with primary hypercholesterolemia (non-familial) or mixed dyslipidemia . This...
Study of Plozasiran in Adults With Severe Hypertriglyceridemia at Risk of Acute Pancreatitis
This study will evaluate the efficacy and safety of plozasiran in approximately 288 adult participants with severe hypertriglyceridemia (SHTG) and history of at least two prior...
A Study to Evaluate the Effect of Obicetrapib/Ezetimibe 10 mg Fixed-Dose Combination or Obicetrapib 10 mg Daily on Top...
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...
Study to Evaluate Efficacy and Safety of Inclisiran in Children With Heterozygous Familial Hypercholesterolemia
This is a pivotal phase III study designed to evaluate safety, tolerability, and efficacy of inclisiran in children (aged 6 to \<12 years) with heterozygous familial...
Evaluation of Efficacy and Safety of Early in Hospital Initiation of Inclisiran Treatment in Patients With Acute...
The purpose of this trial is to learn about the effects of inclisiran in people with serious heart conditions (acute coronary syndromes), when this treatment is started early...
What Participation Looks Like
Phase 3 trials for Hyperlipidemia typically enroll several hundred to several thousand participants across multiple sites. Participation involves a screening visit to confirm eligibility, randomization to either the investigational treatment or a comparator (often the current standard of care), regular study visits over months or years, and follow-up after the active treatment period. The protocols, time commitments, and visit schedules differ from trial to trial — read the per-trial page for the specifics before discussing participation with your doctor.
Each trial begins with informed consent and a screening visit, where the study team confirms eligibility against the inclusion and exclusion criteria. Randomization assigns participants to either the investigational treatment or a comparator. Standard-of-care portions of the protocol are typically billed to insurance; trial-specific procedures (extra imaging, biopsies, lab draws beyond standard care) are usually covered by the sponsor. Read each trial\'s detailed page for its specific time commitment and visit schedule.
Authoritative Resources for Hyperlipidemia Trials
Verify any individual trial directly on ClinicalTrials.gov. For the federal context on how Phase 3 results feed into approval decisions, see the FDA drug approval process. For oncology-specific trial resources, the National Cancer Institute publishes patient-oriented overviews. For trials registered outside the U.S., the WHO ICTRP aggregates registries from around the world.
Frequently Asked Questions
What is a Phase 3 Hyperlipidemia trial?
A Phase 3 trial is the final stage of clinical testing before a treatment can be submitted to the FDA for approval. For Hyperlipidemia, Phase 3 studies typically enroll hundreds to thousands of patients across multiple medical centers, comparing the new treatment to the current standard of care or a placebo (where ethically appropriate). The goal is to confirm efficacy, monitor side effects in a larger population, and generate the evidence the FDA needs to make an approval decision.
How many Phase 3 Hyperlipidemia trials are recruiting?
9 Phase 3 trials for Hyperlipidemia are currently registered on ClinicalTrials.gov. Recruitment status varies by trial — some are actively enrolling, some have closed enrollment but are still in the active treatment phase, and some are completing follow-up. Click any trial below to see its current status, eligibility criteria, and contact information.
Who can participate in a Phase 3 Hyperlipidemia trial?
Phase 3 eligibility depends entirely on the specific trial protocol. Each trial sets its own inclusion criteria (typically a confirmed diagnosis, certain disease stage or severity, age range) and exclusion criteria (often previous treatments, comorbidities, lab values that fall outside set ranges). The trial pages on this site translate the clinical eligibility criteria into plain English alongside the original text. Whether you fit any specific trial is a medical decision your doctor needs to confirm.
Is participating in a Phase 3 Hyperlipidemia trial safe?
Phase 3 trials use treatments that have already passed Phase 1 (safety in small groups) and Phase 2 (initial efficacy and side-effect monitoring), so the safety profile is better understood than in earlier-phase studies. That said, side effects can still emerge in larger populations, and the trial protocol may require additional procedures (lab draws, imaging, biopsies) beyond standard care. The informed consent document for any specific trial details the known risks. Discuss those risks with your physician before deciding whether to participate.
Where does this trial data come from?
All trial data is sourced from the ClinicalTrials.gov API v2, the federal registry maintained by the National Library of Medicine at NIH. Under FDAAA 801, most U.S. drug and device trials must register on ClinicalTrials.gov, making it the most comprehensive source of trial information. Sponsors are required to update trial status within 30 days of a change, but delays occur — always confirm the current status with the trial site before traveling for screening.
How This Page Is Built
The trial list is filtered to ClinicalTrials.gov registrations whose phase field includes Phase 3 and whose condition list includes Hyperlipidemia. Trial counts and the sponsor leaderboard are computed from the same record set. Plain-English eligibility translations on each linked trial page preserve the original clinical text alongside the accessible version. Read the full methodology for the data pipeline and known limitations.
Source: ClinicalTrials.gov API v2, maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData, Phase 3 Hyperlipidemia list, May 2026. Data: ClinicalTrials.gov."
Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.
Last updated 2026-05-08 · 9 Phase 3 trials tracked for Hyperlipidemia.
The this entity category groups every U.S. clinical trials and research registries entity sharing this attribute. The list above is the data; the paragraphs below explain what the grouping means against the broader the NIH ClinicalTrials.gov registry distribution and how to read the relative rankings within the category.
For readers using this category as a starting point, the per-entity detail pages linked from the table above carry the underlying the NIH ClinicalTrials.gov registry data in full. The category-level view is the filter; the per-entity pages are the actual answer.