DII235 for High Cholesterol

Recruiting at 27 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Novartis Pharmaceuticals

Must not be taking: Investigational medications

Disqualifiers: Severe renal dysfunction, Hepatic dysfunction, Malignancy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the safety and effectiveness of a new drug, DII235, for adults with high cholesterol, specifically elevated levels of lipoprotein(a), a type of fat in the blood. The trial compares different doses of DII235 to a placebo (a harmless pill with no active drug) to assess its efficacy. Ideal participants have a history of heart disease or type 2 diabetes and know they have high lipoprotein(a) levels. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important early findings.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that DII235 is likely to be safe for humans?

Research is examining the safety of DII235 for adults with elevated levels of lipoprotein(a), a type of cholesterol. While specific safety results for DII235 are not yet available, its advancement to Phase 2 indicates some safety in earlier studies. In Phase 2, researchers assess how well participants tolerate the treatment and monitor any side effects. This phase is crucial for understanding safety, so participants receive close monitoring. Those considering joining a trial with DII235 should know that this treatment is still under evaluation to ensure its safety and effectiveness. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about DII235 for high cholesterol because it offers a novel approach compared to existing treatments like statins, which mainly work by inhibiting cholesterol production in the liver. DII235 is unique because it targets cholesterol metabolism through a different pathway, potentially offering benefits for patients who do not respond well to current options. Additionally, DII235 is being tested in multiple doses, which may help identify the most effective and safest dose for patients. This new mechanism and tailored dosing strategy could provide a more personalized approach to managing high cholesterol.

What evidence suggests that DII235 might be an effective treatment for high cholesterol?

Research shows that DII235 is under investigation for its potential to lower high levels of lipoprotein(a), a type of cholesterol linked to heart issues. The trial includes several arms testing different doses of DII235, along with a placebo comparator. Although detailed results from human studies on DII235 remain limited, it operates similarly to other cholesterol-lowering drugs that have effectively reduced lipoprotein(a). These drugs have demonstrated significant cholesterol reductions, suggesting a promising approach for DII235. Early findings indicate that DII235 might also lower cholesterol, but ongoing studies will provide a clearer picture of its effectiveness. ^{1 6 7 8 9}

Who Is on the Research Team?

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

Are You a Good Fit for This Trial?

This trial is for adults aged 18-80 with high levels of lipoprotein(a), a risk factor for heart disease. Participants may also have type 2 diabetes or evidence of cardiovascular disease. They must understand and agree to the study's requirements by signing an informed consent form.

Inclusion Criteria

I am between 18 and 80 years old.

I have signed the consent form to participate in this study.

My Lp(a) level is 150 nmol/L or higher.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive DII235 or placebo, with doses evaluated for efficacy and safety

52 weeks

Regular visits for dose administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• DII235

Trial Overview

The trial is testing DII235, a potential new treatment for lowering lipoprotein(a) levels, against saline (a placebo). The goal is to assess how safe and effective DII235 is in reducing this risk factor for heart-related conditions.

How Is the Trial Designed?

Group I: Arm 5 Experimental Treatment 1 Intervention

DII235 dose 4

Group II: Arm 4 Experimental Treatment 1 Intervention

DII235 dose 3

Group III: Arm 3 Experimental Treatment 1 Intervention

DII235 dose 2

Group IV: Arm 2 Experimental Treatment 1 Intervention

DII235 dose 1

Group V: Arm 1 Placebo Group 1 Intervention

Placebo

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals

Lead Sponsor

Trials

2,963

Recruited

4,275,000+

Founded

1996

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Gleevec, Cosentyx, Entresto, Kisqali

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07235046

A Study of DII235 in Adults With Elevated Lipoprotein(a)

Study Overview​​ The main purpose of this study is to determine the safety and efficacy of DII235 in adults with elevated lipoprotein(a).

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12282488/

Current Clinical Trials for Treating Elevated Lipoprotein(a)

Phase 3 trials will be crucial in determining the viability of lowering Lp(a) with such therapies and improving cardiovascular outcomes. Summary.

3.

prnewswire.com

prnewswire.com/news-releases/amgen-presents-long-term-data-showing-efficacy-and-safety-of-investigational-cholesterol-lowering-medication-evolocumab-across-lipid-and-ldl-c-levels-283097421.html

Amgen Presents Long-Term Data Showing Efficacy And ...

Results showed reductions of 72 percent for evolocumab 140 mg every two weeks (measured one week after dosing) and 69 percent for evolocumab 420 ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39003112/

Effectiveness and safety of alirocumab and evolocumab for ...

Results: A total of 193 patients treated with PCSK9i were followed for a median of 27 months (IQR 23). The median age was 61 (IQR 15); 62.7% ...

5.

cdek.pharmacy.purdue.edu

cdek.pharmacy.purdue.edu/trial/NCT07235046/

Trial | NCT07235046

The main purpose of this study is to determine the safety and efficacy of DII235 in adults with elevated lipoprotein(a). Detailed Description. None. Timeline.

6.

novartis.com

novartis.com/clinicaltrials/study/nct07235046

A Study of DII235 in Adults With Elevated Lipoprotein(a)

Study Description. The main purpose of this study is to determine the safety and efficacy of DII235 in adults with elevated lipoprotein(a).

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04023552

NCT04023552 | Assessing the Impact of Lipoprotein (a) ...

This is a pivotal phase 3 study designed to support an indication for the reduction of cardiovascular risk in patients with established CVD and elevated Lp(a)

8.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38057066/

Safety and Tolerability of Inclisiran for Treatment ...

Long-term treatment with inclisiran was well tolerated in a diverse population, without new safety signals, supporting the safety of ...

9.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11773273/

Achievement of guideline-based lipid goals among very-high ...

Achieving guideline-based lipid goals is crucial for these VHR patients because it significantly reduces cardiovascular and mortality risks. The ...