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

NCT06606483 | Not Yet Recruiting Phase 2

• 1 other identifier: MDR-001-CN-02
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 19

Brief Summary

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.

Conditions

Obesity; Overweight and Obesity

Outcome Measures

Primary Outcomes (1)

• Percent Change in Body Weight From Baseline at Week 24

  Baseline, Week 24

Secondary Outcomes (8)

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

  Baseline, Week 24

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

  Baseline, Week 24

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

  Baseline, Week 24

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

  Baseline, Week 24

• Change in Waist Circumference from Baseline at Week 24

  Baseline, Week 24

Other Outcomes (4)

• To assess safety and tolerability of study interventions

  up to 25 weeks

• The time-course variation of MDR-001 plasma concentration

  up to 25 weeks

• MDR-001 Population Pharmacokinetic (PopPK) Analysis

  up to 25 weeks

Study Arms (5)

90 mg MDR-001

EXPERIMENTAL

Drug: MDR-001 Administered orally

Drug: MDR-001

120 mg MDR-001

EXPERIMENTAL

Drug: MDR-001 Administered orally

Drug: MDR-001

150 mg MDR-001

EXPERIMENTAL

Drug: MDR-001 Administered orally

Drug: MDR-001

180 mg MDR-001

EXPERIMENTAL

Drug: MDR-001 Administered orally

Drug: MDR-001

placebo

PLACEBO COMPARATOR

Drug: MDR-001 Administered orally

Drug: Placebo

Interventions

MDR-001 DRUG

Oral administration of small molecule MDR-001 tablets

120 mg MDR-001; 150 mg MDR-001; 180 mg MDR-001; 90 mg MDR-001

Placebo DRUG

Administered orally placebo

placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• obesity: ≥28 kg/m2
• overweight: ≥24 kg/m2 and ≤28 kg/m2 with at least 1 of the following weight-related comorbidities
• \) prediabetes: 6.1 mmol/L (110 mg/dL) ≤FPG≤7.0 mmol/L (126 mg/dL) ; and/or 5.7%≤HbA1c≤6.5% 2）Hypertension: medical record for Hypertension, or diagnosis of hypertension for the first time during screening (with at least three measurements spaced across at least over a period of two days, defining hypertension as a systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg).
• \) Dyslipidemia: medical record for dyslipidemia (regardless of medication treatment) or TC≥5.2 mmol/L (200 mg/dl), and/or LDL-C≥3.4 mmol/L (130 mg/dl), and/or HDL-C\<1.0 mmol/L (40 mg/d l), and/or TG≥1.7 mmol/L (150 mg/dl) at screening 4) fatty liver disease(FLD): Presence of FLD confirmed by imaging studies within three months prior to screening, or diagnosis of FLD at screening 5) obstructive sleep apnea 6) Presence of weight-bearing joint pain during the screening period or within three months prior to screening. (Acceptance of patient self-description)
• The weight change achieved through dietary and exercise control should not exceed a 5% variation within three months prior to screening. (Acceptance of patient self-description)
• Potential participants with fertility potential (including the partners of male participants) must not have any plans for conception or sperm donation from the screening period until 6 months after the last dose administration, and they should be willing to use at least one effective contraception method.
• The participant must have a thorough understanding of the trial objectives, be able to communicate effectively with the investigators, and be capable of comprehending and adhering to all the requirements of this trial, including following the medication regimen and lifestyle guidance as outlined in the protocol.

You may not qualify if:

• 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 \&lt;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.
• A history of suicidal ideation or suicidal behavior.
• Have any of the following major cardiovascular and cerebrovascular conditions within 6 months prior to Screening 1) myocardial infarction(MI), percutaneous coronary intervention(PCI), coronary artery bypass grafting(CABG), heart valve repair/replacement, unstable angina, hemorrhagic stroke (stroke), ischemic stroke (including transient ischemic attack (TIA)); 2) New York Heart Association Functional Classification III or IV congestive heart failure
• A history of gout within the past six months prior to screening.
• A history of proliferative retinopathy or macular degeneration.
• Have a history of malignancy less than 5 years or diagnosis of malignancy at screening (other than cured basal cell skin cancer, or in situ carcinomas of the cervix)
• Have a known self or family history (first-degree relative) of medullary thyroid carcinoma or multiple endocrine neoplasia type 2
• Have a personal or family history of long QT syndrome, family history of sudden death in a first-degree relative (parents, siblings, or children) before the age of 40 years, and/or a personal history of unexplained syncope within the last year.
• During the screening phase, subjects exhibited thyroid function abnormalities uncontrolled (TSH\&gt;6 mIU/L or \&lt;0.4 mIU/L) by a stable medication regimen (stable dosages for three months or more), Subclinical hypothyroidism requiring no treatment (with TSH levels \&lt;10.0 mIU/L and normal range of FT3 and FT4) is excluded.
• Within the six months preceding screening, subjects experienced severe gastrointestinal disorders (such as active gastric ulcers), or underwent gastrointestinal surgery (Appendectomy, cholecystectomy, or other gastrointestinal endoscopic surgeries deemed by the investigator to have no significant impact on gastrointestinal motility are excluded), or have a known clinically significant gastric emptying abnormality (for example, pyloric obstruction, gastroparesis)
• Amylase/lipase\>3 ULN at screening or have had a history of chronic or acute pancreatitis
• Have had a history of chronic or acute hepatitis; or have signs and symptoms of any other liver disease other than nonalcoholic fatty liver disease at screening, or any of the following, as determined by the laboratory during screening 1）ALT or AST ≥3×ULN 2）TBIL≥1.5×ULN 3）ALP≥3×ULN

Sponsors & Collaborators

• MindRank AI Ltd: lead

Study Sites (19)

The Second Hospital Of Anhui Medical University

Hefei, Anhui, China

Location

The People's Hospital of Suancheng City

Xuancheng, Anhui, China

Location

Zibo Central Hospital

Zibo, Anhui, China

Location

Peking University People's Hospital

Beijing, Beijing Municipality, China

Location

The Third People's Hospital of Hainan

Haikou, Hainan, China

Location

The Second Hospital Of Hebe Medical University

Shijiazhuang, Hebei, China

Location

The Fourth Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Location

The first Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, China

Location

The First Affiliated Hospital of Nanyang Medical College

Nanyang, Henan, China

Location

The First People's Hospital of Chenzhou City

Chenzhou, Hunan, China

Location

Zhuzhou Central Hospital

Zhuzhou, Hunan, China

Location

Second Hospital of Jilin University

Changchun, Jilin, China

Location

Daqing People's Hospital

Daqing, Jilin, China

Location

Panjin Liaoyou Gem Flower Hospital

Panjin, Liaoning, China

Location

The Fifth People's Hospital of Shenyang

Shenyang, Liaoning, China

Location

Central hospital of Jinan

Jinan, Shandong, China

Location

Shanxi Bethune Hospital

Taiyuan, Shanxi, China

Location

Xianyan Hospital of Yanan Univisity

Xianyang, Shanxi, China

Location

Yichang Central People's Hospital

Yichang, Sichuan, China

Location

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ruowen Guo

CONTACT

+86 0571-85233836; ruowen.guo@mindrank.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2024
• First Posted: September 23, 2024
• Study Start: September 23, 2024
• Primary Completion: July 30, 2025
• Study Completion: September 30, 2025
• Last Updated: September 24, 2024

Record last verified: 2024-09

Locations

CN (19)