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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

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.
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).
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
Select...
I am between 18 and 79 years old.
Select...
I am using a combined hormonal contraceptive.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Evaluate the efficacy of NST-1024 by percentage change in TG
Secondary study objectives
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

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Who is running the clinical trial?

NorthSea Therapeutics B.V.Lead Sponsor
6 Previous Clinical Trials
538 Total Patients Enrolled
~3 spots leftby Dec 2024
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