A Clinical Trial to Investigate the Safety and Efficacy of MB-1 on Metabolic Health in Overweight and Obese Adults
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorArrae
About this trial
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.
Eligibility criteria
Qualifiers
Males & females aged 18-50 years, inclusive
BMI of 25.0 to ≤ 34.9 kg/m²
Females not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to screening Or,
Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
Disqualifiers
Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
Allergy, sensitivity, or intolerance preventing consumption of the investigational product or placebo ingredients
Gastric bypass surgery or other surgeries to induce weight loss
Metal implants or other physical characteristics/limitations that may affect DEXA scan results as assessed by the QI
Trial design
Treatments tested in this trial
- MB-1
- Placebo
Treatment groups
120 Participants
are divided into 2 treatment groupsSponsors and collaborators
Arrae
Lead sponsor
KGK Science Inc.
Collaborator
Source ClinicalTrials.gov