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Protein

Pep19 5 mg for Quality of Life

N/A

Recruiting

Led By Jason Haffizulla, MD

Research Sponsored by Proteimax Biotechnology Israel LTD

Eligibility Criteria Checklist

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

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 60 days

Awards & highlights

Study Summary

This trial will assess the impact of Pep19 on the quality of life and sleep patterns of obese individuals. Pep19 is a safe protein that can promote fat loss without affecting the brain, heart, pancre

Who is the study for?

This trial is for generally healthy adults aged 40-60 with obesity, defined as having a BMI between 30 and 35. Participants must be able to attend clinic appointments for qualification and follow-ups.Check my eligibility

What is being tested?

The study tests the effects of Pep19, a protein that may reduce body fat without affecting the brain or heart. Two doses (2 mg and 5 mg) are compared against a placebo to see if they improve quality of life and sleep in obese individuals.See study design

What are the potential side effects?

Pep19 has been well tolerated in previous studies with animals and humans, showing no significant side effects. It's not allergenic or mutagenic, nor does it contain harmful microbes or metals.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 60 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~60 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 days for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Improvement on QoL

Improvement on Sleep quality

Secondary outcome measures

Blood pressure

Body fat

Body weight

+4 more

Trial Design

3Treatment groups

Active Control

Placebo Group

Group I: Pep19 5 mgActive Control1 Intervention

Group II: Pep19 2 mgActive Control1 Intervention

Group III: placeboPlacebo Group1 Intervention

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Proteimax Biotechnology Israel LTDLead Sponsor

Jason Haffizulla, MDPrincipal InvestigatorPrecision Clinical Research

Frequently Asked Questions

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

Is this research study currently accepting new participants?

"Confirmed. The data available on clinicaltrials.gov indicates that this particular medical investigation is actively seeking suitable candidates for participation. Initially shared on April 17, 2024, and most recently modified on the same day, the research aims to recruit a total of 24 individuals from a single designated site."

Answered by AI

What is the primary objective of this clinical trial endeavor?

"As outlined by the sponsor, Proteimax Biotechnology Israel LTD, this research aims to enhance sleep quality within a 60-day timeframe. Secondary measures will include blood biomarkers such as triglycerides, ALT, AST, C-reactive protein, glucose, insulin, and HgBA1c presented in mmol/L units; body fat percentages determined via DEXA scan; and heart rate assessed using a device recording beats per second."

Answered by AI

What is the current number of subjects participating in this investigation?

"Indeed, information available on clinicaltrials.gov confirms the ongoing recruitment of participants for this medical trial. Initially shared on April 17, 2024, and last modified that same day, the study aims to enroll 24 individuals from a single site."

Answered by AI

Is it possible for me to enroll as a participant in this research study?

"This research project seeks to enroll 24 individuals aged between 40 and 60 who are community-dwelling, generally healthy adults. They must have a body mass index (BMI) ranging from 30 to 35 kg/m2 and be capable of visiting the clinic for assessments and subsequent visits."

Answered by AI