NCT06359327

Brief Summary

Pep19 is a naturally occurring peptide (protein) that triggers loss of body fat. It has been certified Generally Recognized as Safe (GRAS) at up to 3.8 grams per day and may be included in various foods. Pep19 has no effect on the brain, heart, pancreas or skeletal muscle. It is highly purified, not allergenic or mutagenic, and free of microbes, metals and other contaminants. Preliminary, open-label, uncontrolled studies have shown that Pep19 is well tolerated in rodents, dogs, and humans. This placebo-controlled study will evaluate the effects of two doses of Pep19™ -- 2 mg and 5 mg - on quality of life and sleep quality in obese subjects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable quality-of-life

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable quality-of-life

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 11, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

May 28, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 28, 2024

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2024

Completed
Last Updated

November 6, 2024

Status Verified

November 1, 2024

Enrollment Period

2 months

First QC Date

March 27, 2024

Last Update Submit

November 4, 2024

Conditions

Quality of LifeObesitySleep Quality

Keywords

PeptideBody weight managmentSleep

Outcome Measures

Primary Outcomes (2)

  • Improvement on QoL

    The study main endpoint is QoL. The study involves standard assessments, in the study will use the questionnaires SF-12 to assess quality of life.

    60 days

  • Improvement on Sleep quality

    Related to QoL, the study will use the questionnaires PSQI to assess quality of sleep.

    60 days

Secondary Outcomes (7)

  • Temperature

    60 days

  • Blood pressure

    60 days

  • Heart rate

    60 days

  • circumference

    60 days

  • blood tests

    60 days

  • +2 more secondary outcomes

Study Arms (3)

placebo

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Pep19 2 mg

ACTIVE COMPARATOR
Dietary Supplement: Pep19 2 mg

Pep19 5 mg

ACTIVE COMPARATOR
Dietary Supplement: Pep19 5 mg

Interventions

PlaceboDIETARY_SUPPLEMENT

Subjects will be given an informed consent as per the form submitted to Advarra IRB. 8 randomized subjects will be given placebo for 60 days. Placebo will be formulated as a dietary supplement in veggie capsules with microcrystalline cellulose excipient.

placebo
Pep19 2 mgDIETARY_SUPPLEMENT

Subjects will be given an informed consent as per the form submitted to Advarra IRB. 8 randomized subjects will be given 2 mg of Pep19 for 60 days. Placebo will be formulated as a dietary supplement in veggie capsules with microcrystalline cellulose excipient.

Pep19 2 mg
Pep19 5 mgDIETARY_SUPPLEMENT

Subjects will be given an informed consent as per the form submitted to Advarra IRB. 8 randomized subjects will be given 5 mg of Pep19 for 60 days. Placebo will be formulated as a dietary supplement in veggie capsules with microcrystalline cellulose excipient.

Pep19 5 mg

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Generally healthy adults between the ages of 40 and 60 years of age, i.e., adults who are community living and able to come to the clinic for qualification and followup appointments
  • BMI between 30 and 35 kg/m2

You may not qualify if:

  • Pregnancy, lactation
  • Anti-obesity supplements or medications, e.g. semaglutide

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Precision Clinical Research, LLC

Sunrise, Florida, 33351, United States

Location

Related Publications (2)

  • Reckziegel P, Festuccia WT, Britto LRG, Jang KLL, Romao CM, Heimann JC, Fogaca MV, Rodrigues NS, Silva NR, Guimaraes FS, Eichler RAS, Gupta A, Gomes I, Devi LA, Heimann AS, Ferro ES. A novel peptide that improves metabolic parameters without adverse central nervous system effects. Sci Rep. 2017 Nov 1;7(1):14781. doi: 10.1038/s41598-017-13690-9.

    PMID: 29093454BACKGROUND

  • Silverio R, Barth R, Heimann AS, Reckziegel P, Dos Santos GJ, Romero-Zerbo SY, Bermudez-Silva FJ, Rafacho A, Ferro ES. Pep19 Has a Positive Effect on Insulin Sensitivity and Ameliorates Both Hepatic and Adipose Tissue Phenotype of Diet-Induced Obese Mice. Int J Mol Sci. 2022 Apr 7;23(8):4082. doi: 10.3390/ijms23084082.

    PMID: 35456900BACKGROUND

MeSH Terms

Conditions

ObesitySleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Jason Haffizulla, MD

    Precision Clinical Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2024

First Posted

April 11, 2024

Study Start

May 28, 2024

Primary Completion

July 28, 2024

Study Completion

August 15, 2024

Last Updated

November 6, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)