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Evaluate the Efficacy and Safety of EN001 in Patients With Sarcopenia

ConditionSarcopenia
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age60+
SponsorENCell

About this trial

A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase 1/2 Clinical Trial to Evaluate the Efficacy and Safety of EN001 in Patients with Sarcopenia

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Natural amenorrhea for 12 months

At least 6 weeks after surgical menopause (bilateral oophorectomy)

(1) Handgrip Strength: < 28kg(men), <18kg(women)

(2) 6-Metre Walk test<1.0m/s, or 5-Times Chair Stand Test ≥12seconds, or Short Physical Performance Battery(SPPB)≤9points

Disqualifiers

1)Those with the following comorbidities confirmed at the time of screening and baseline

Patients with chronic kidney disease(CKD-EPI;Estimated Glomerular Filtration Rate(eGFR) <30 mL/min)

Individuals with uncontrolled thyroid disease(hyperthyroidism or hypothyroidism)

Patients with uncontrolled diabetes(HbA1c >8.5%)

Trial design

Design model

Parallel

Treatments tested in this trial

  • EN001

    Drug

    \- Phase1-Cohort 1: EN001 Low dose administered intravenously (IV) 3 times at 4 week intervals.

  • EN001

    Drug

    -Phase2-Cohort 2 : EN001 Medium dose administered intravenously (IV) 3times at 4 week intervals.

  • EN001

    Drug

    -Phase1-Cohort 3 : EN001 High dose administered intravenously (IV) 3times at 4 week intervals.

  • EN001

    Drug

    -Phase2-Cohort 1 : EN001 Low dose(Recommended Phase 2 Dose\[RP2D\] of EN001) administered intravenously (IV) 3times at 4 week intervals.

  • EN001

    Drug

    -Phase2-Cohort2 : EN001 High dose(Recommended Phase 2 Dose\[RP2D\] of EN001) administered intravenously (IV) 3times at 4 week intervals.

  • EN001 Placebo

    Drug

    -Phase2-Placebo : EN001 Placebo administered intravenously (IV) 3times at 4 week intervals.

Treatment groups

132 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Phase1 - Cohort 1Active comparator 1 intervention
Group B: Phase1 - Cohort 2Active comparator 1 intervention
Group C: Phase1 - Cohort 3Active comparator 1 intervention
Group D: Phase2 - Cohort 1Active comparator 1 intervention
Group E: Phase2 - Cohort 2Active comparator 1 intervention
Group F: Phase2 - PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

[Phase1] Dose limiting toxicity (DLT) and adverse drug reactions related to discontinuation of investigational product administration

Present the frequency and percentage of dose-limiting toxicity (DLT) occurrence across dose cohorts, along with detailed information on the types of DLTs. Adverse events related to discontinuation of clinical investigational drug administration, discontinuation of clinical investigational drug administration Regarding related adverse drug reactions, the number of subjects in each cohort, incidence rate (%), and Two-sided 95% confidence intervals and number of occurrences are presented.

Time frame
Up to 12 weeks
2

[Phase2] Change from baseline in the SPPB(Short Physical Performance Battery) at Week 24

For all efficacy outcome measures, descriptive statistics (number of subjects, mean, standard deviation, median, minimum, and maximum) will be presented by treatment group and assessment time point, along with two-sided 95% confidence intervals.

Time frame
at Week 24

Secondary outcomes

1

[Phase1, Phase2] SPPB(Short Physical Performance Battery) score change

Present the subject count, mean, standard deviation, median, minimum, and maximum for the changes at each time point within each dosage group.

Time frame
At 4,8,12, 18, and 24 weeks compared to baseline(Visit2)
2

[Phase1, Phase2] Change in handgrip strength

Present the subject count, mean, standard deviation, median, minimum, and maximum for the changes at each time point within each dosage group.

Time frame
At 4,8,12, 18, and 24 weeks compared to baseline(Visit2)
3

[Phase1, Phase2] Change in time to complete the 5-Times Chair Stand Test

Present the subject count, mean, standard deviation, median, minimum, and maximum for the changes at each time point within each dosage group.

Time frame
At 4,8,12, 18, and 24 weeks compared to baseline(Visit2)
4

[Phase1, Phase2] Change in 6-Minute Walk Test (6MWT) distance

Present the subject count, mean, standard deviation, median, minimum, and maximum for the changes at each time point within each dosage group.

Time frame
At 4,8,12, 18, and 24 weeks compared to baseline(Visit2)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

ENCell

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: