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A Clinical Trial to Investigate the Safety and Efficacy of MB-1 on Metabolic Health in Overweight and Obese Adults

StatusRecruiting
PhaseNot applicable
SponsorArrae
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Notable Recruitment opened Show 5 more changesShow less
    • Primary and study completion dates: Jan 2027 to Feb 2027
    • Start date changed from estimate of Aug 2026 to Aug 5, 2026
    • Eligibility criteria expanded, about 21 words
    • Secondary endpoints: details revised at 1 of 13 entries
    • Site details revised
  2. Notable Primary completion pushed from Apr 2026 to Jan 2027v3 Show 6 more changesShow less
    • Primary endpoint(s) modified
    • Start date: Apr 2026 to Aug 2026
    • Enrollment increased: 100 → 120 participants
    • Study completion pushed from Jul 2026 to Jan 2027
    • Eligibility criteria shortened, about 9 words
    • Secondary endpoints: 16 to 13
  3. Minor Re-verified, no change to tracked fieldsv2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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The goal of this clinical trial is to investigate the safety and efficacy of MB-1 on metabolic health in overweight and obese adults. The main question it aims to answer is: What is the difference in change in body weight from baseline at Day 84 between MB-1 and placebo? Participants will be provided MB-1 or placebo and be assessed for anthropometric measurements, blood pressure, heart rate, and asked to complete appetite and satiety questionnaires and undergo a DEXA scan.
Trial Details
NCT Number NCT07363148
Lead Sponsor Arrae
Collaborators: KGK Science Inc.
Conditions
(from sponsor)
Obese, Overweight Adults, Obese Adults, Body Weight Control, BMI
Related terms Obesity, Overweight
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov