A Study to Evaluate the Efficacy and Safety of MDR-001 in Subjects Who Are Obesity or Overweight
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorMindRank AI Ltd
About this trial
This is a 24 weeks, multicenter, randomized, double-blind, placebo, parallel-controlled Phase IIb trail comparing the efficacy and safety of MDR-001 tablet versus placebo as an adjunct to a reduced calorie diet and increased physical activity in subjects with overweight or obesity, and to explore the optimal dose selection to support the subsequent Pivotal trial.
Eligibility criteria
Qualifiers
In accordance with adequate informed consent, the subject voluntarily signs the Informed Consent Form (ICF).
Male or female participants aged ≥18 and ≤ 65 years, who have signed the Informed Consent Form (ICF)
Have BMI of
overweight: ≥24 kg/m2 and ≤28 kg/m2 with at least 1 of the following weight-related comorbidities
Disqualifiers
Have obesity induced by other disorders or drugs, including elevated cortisol hormones (such as Cushing's syndrome), polycystic ovary syndrome, obesity due to pituitary and hypothalamic injuries, etc
Previous diagnosis of diabetes mellitus (including Type 1 diabetes, Type 2 diabetes, diabetes caused by pancreatic injury, or other types of diabetes) or diagnosis of Type 2 diabetes at the time of screening/randomization, defined as: HbA1c ≥ 6.5%; and/or fasting plasma glucose ≥ 7.0 mmol/L (126 mg/dL); and/or random plasma glucose ≥ 11.1 mmol/L (200 mg/dL).
A history of at least one episode of hypoglycemia occurring within the 3 months prior to screening, without apparent precipitating causes, is defined as FPG <2.8 mmol/L (50 mg/dL) and/or the presence of marked symptoms of hypoglycemia.
A history of psychiatric disorders, addictive diseases, or other conditions that may impair the ability of the participant to provide informed consent.
Trial design
Treatments tested in this trial
- MDR-001
- Placebo
Treatment groups
300 Participants
are divided into 5 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov