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A Study to Evaluate the Efficacy and Safety of MDR-001 in Subjects Who Are Obesity or Overweight

ConditionsObesityOverweight and Obesity
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • MDR-001

    Drug

    Oral administration of small molecule MDR-001 tablets

  • Placebo

    Drug

    Administered orally placebo

Treatment groups

300 Participants
are divided into 5 treatment groups
Group A: 90 mg MDR-001Experimental treatment 1 intervention
Group B: 120 mg MDR-001Experimental treatment 1 intervention
Group C: 150 mg MDR-001Experimental treatment 1 intervention
Group D: 180 mg MDR-001Experimental treatment 1 intervention
Group E: placeboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percent Change in Body Weight From Baseline at Week 24

Time frame
Baseline, Week 24

Secondary outcomes

1

Change in Body Weight (kg) from Baseline at Week 24

Time frame
Baseline, Week 24
2

Percentage of Study Participants Who Achieve ≥5% Body Weight Reduction at Week 24

Time frame
Baseline, Week 24
3

Percentage of Study Participants Who Achieve ≥10% Body Weight Reduction at Week 24

Time frame
Baseline, Week 24
4

Change in BMI (kg/m2) from Baseline at Week 24

Time frame
Baseline, Week 24

Other outcomes

1

To assess safety and tolerability of study interventions

Time frame
up to 25 weeks
2

The time-course variation of MDR-001 plasma concentration

Time frame
up to 25 weeks
3

MDR-001 Population Pharmacokinetic (PopPK) Analysis

Time frame
up to 25 weeks
4

Percentage of Study Participants Who Achieve ≥15% Body Weight Reduction at Week 24

Time frame
Baseline, Week 24

Sponsors and contacts

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

MindRank AI Ltd

Lead sponsor

Source ClinicalTrials.gov

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