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NST-1024 for High Triglycerides

Phase 2

Recruiting

Research Sponsored by NorthSea Therapeutics B.V.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Men or women 18 to 79 years of age, inclusive;

Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up ~ 8 weeks

Awards & highlights

Study Summary

This trial will test if a drug can help reduce high triglyceride levels in 50 people.

Who is the study for?

This trial is for adults aged 18-79 with very high triglyceride levels (≥500 mg/dL and ≤2000 mg/dL). Participants must understand the study, follow its schedule, and give written consent. Women can join if they're not pregnant or breastfeeding, have had a hysterectomy or tubal ligation, are post-menopausal, or use effective contraception. Men's partners must also use effective birth control.Check my eligibility

What is being tested?

The trial tests NST-1024 against a placebo in reducing triglycerides as an addition to diet changes over 28 days. It's a Phase IIa study with about 50 participants across multiple U.S. centers who will be randomly assigned to either the drug or placebo group in a double-blind setup (neither doctors nor patients know who gets what).See study design

What are the potential side effects?

While specific side effects of NST-1024 aren't listed here, common ones for drugs treating high triglycerides include stomach pain, back pain, headaches, nausea and increased liver enzyme levels which could indicate potential liver damage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 79 years old.

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I am using a combined hormonal contraceptive.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ ~ 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~~ 8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and ~ 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Evaluate the efficacy of NST-1024 by percentage change in TG

Secondary outcome measures

Change in hsCRP

Change in insulin resistance.

Change in lipoprotein associated phospholipase A2

+6 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: NST-1024Active Control1 Intervention

NST-1024 400 mg BID

Group II: Matched PlaceboPlacebo Group1 Intervention

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

NorthSea Therapeutics B.V.Lead Sponsor

6 Previous Clinical Trials

538 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible to participate in this experiment?

"In order to be admitted into the trial, applicants must have elevated levels of triglycerides and should fall between 18 and 79 years old. At maximum, 50 people can take part in this study."

Answered by AI

Is there an age restriction on participants in this medical experiment?

"The parameters for patient inclusion are such that the minimum age is 18, while the maximum allowable age is 79."

Answered by AI

Are new participants able to join this experiment at present?

"Affirmative. According to the information on clinicaltrials.gov, this medical experiment is seeking enrollees. It was initially announced in late June of 2023 and revised for a final time at the end of December that same year. 50 people must be enrolled from 31 different locations for this study to progress properly."

Answered by AI

How many medical facilities are conducting this clinical experiment?

"Currently, 31 clinical sites are recruiting for this medical trial. Notably, Velocity Clinical Research in La Mesa and Alliance for Multispecialty Research locations in Daphne and Tempe are enrolling patients as well as 28 other centres."

Answered by AI

Has NST-1024 earned regulatory approval from the FDA?

"The safety profile of NST-1024 has been rated a 2 since, while there is some evidence for its security, the lack of efficacy data precludes it from receiving a higher score."

Answered by AI

How many test subjects are engaged in this clinical trial?

"NorthSea Therapeutics B.V., the study's sponsor, necessitates 50 suitable patients to carry out the trial from two sites: Velocity Clinical Research in La Mesa, California and Alliance for Multispecialty Research LLC (AMR) - Daphne in Daphne, Arizona."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of the Efficacy and Safety of NST-1024 Versus Placebo in Subjects With Hypertriglyceridemia

2023. "Study of the Efficacy and Safety of NST-1024 Versus Placebo in Subjects With Hypertriglyceridemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05889156.

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