New pill could help shed pounds without surgery
NCT ID NCT07274137
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests an experimental oral drug called MDR-001 to help adults with overweight or obesity lose weight over 52 weeks. About 738 participants will receive either the drug or a placebo, along with lifestyle advice. The main goal is to see if the drug leads to meaningful weight loss compared to placebo.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 738 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Feb 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Have given written informed consent to participate in this study * Chinese male or female participants who are aged 18-65 (inclusive) years at the time of signing the ICF * Participants who are obesity (BMI ≥ 28.0 kg/m2), or overweight (24.0 kg/m2 ≤ BMI \< 28.0 kg/m2) with at least one of the the following weight-related comorbidities at screening:1) Pre-diabetes. 2) Hypertension.3) Dyslipidemia.4) Fatty liver.5) Obstructive sleep apnea syndrome.6) Complaint of weight-bearing joint pain. * Participants had a stable weight maintenance during the 3 months of dietary and physical activity prior to screening (participant-reported data acceptable) and no more than 5% weight fluctuation Exclusion Criteria: * Obesity induced by secondary diseases or drug * Have diabetes mellitus * Have any lifetime history of a suicidal attempt or suicidal behavior * Have a history of depressive disorder * History of gout within 6 months prior to screening * History of major cardiovascular or cerebrovascular disease within 6 months prior to screening, defined as:1)Acute myocardial infarction (MI), percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG), heart valve repair/replacement, unstable angina, hemorrhagic stroke (stroke), ischemic stroke (including transient ischemic attack \[TIA\]).2)Congestive heart failure of New York Heart Association (NYHA) class III or IV.3)Severe arrhythmias * History of malignancy within 5 years prior to screening or newly diagnosed malignancy at screening * Have a family or personal history (parents, children, and siblings of medullary thyroid cancer or Multiple Endocrine Neoplasia Syndrome Type 2 . * Abnormal thyroid function tests at screening not adequately controlled by stable medication doses , or thyroid ultrasound at screening showing thyroid nodules classified as Chinese-thyroid imaging-reporting and data system category 4 or higher. * History of significant gastrointestinal disease or gastrointestinal surgery or clinically significant gastric emptying abnormality within 6 months prior to screening. * History of intestinal disorders deemed clinically significant by the investigator, or acute hemorrhoidal episode within 3 months prior to screening. * History of acute or chronic pancreatitis, or abnormally elevated serum amylase or lipase levels at screening. * revious acute or chronic hepatitis, or symptoms and signs of any other liver disease other than non-alcoholic fatty liver disease, or abnormalities in related laboratory tests at screening * Presence of acute or chronic cholecystitis at screening, or symptomatic or treatment-requiring cholelithiasis/gallbladder polyps at screening, or newly diagnosed cholelithiasis within 6 months before screening * Hypersensitivity or suspected hypersensitivity to glucagon-like peptide 1 receptor agonist (GLP-1RA) drugs or excipients. * History of drug abuse or dependence prior to screening. * Have current or history of treatment with medications that may cause significant weight gain within 3 months prior to screening, including but not limited to: 1. Approved/unapproved marketed weight-loss drugs: orlistat, sibutramine hydrochloride, phentermine, phentermine-topiramate, naltrexone-amfebutamone, tirzepatide, semaglutide, liraglutide, beinaglutide, phendimetrazine, methylamphetamine, etc. 2. Investigational products of weight-loss: Glucagon-like peptide 1 receptor (GLP-1R) agonists, GLP-1R/glucagon receptor (GCGR) agonists, glucose-dependent insulinotropic polypeptide receptor (GIPR)/GLP-1R agonists, GIPR/GLP-1R/GCGR agonists,GLP-1R agonists/activin type II receptor (ActRII) inhibitors, GLP-1R/GIPR/fibroblast growth factor 21 receptor (FGF21R) agonists or FGF21R/GCGR/GLP-1R agonists. 3. Hypoglycemic drugs, such as metformin, sodium-glucose cotransporter 2 (SGLT2) inhibitors, thiazolidinediones (TZDs) or dipeptidyl peptidase 4 (DPP-4) inhibitors. 4. Systemic steroid therapy (including intravenous, oral, intra-articular). 5. Tricyclic antidepressants or other antipsychotic or antiepileptic drugs affecting body weight (e.g., mirtazapine, paroxetine, clozapine, olanzapine, risperidone, quetiapine, paliperidone, valproic acid, valproic acid derivatives, lithium). * History of bariatric surgery (excluding acupuncture/cupping/catgut embedding for bariatric surgery, liposuction, and abdominoplasty performed \>1 year prior to screening) or plans to undergo bariatric surgery or acupuncture/cupping/catgut embedding, liposuction, abdominoplasty during the study period. * Planned chronic use of medications affecting gastrointestinal motility or scheduled gastric emptying-impairing surgery during the study period. * Major or medium-sized surgery, or severe trauma or serious infection within 3 months prior to screening, which, as assessed by the investigator, would preclude trial participation, or planned surgery during the study period (excluding outpatient procedures deemed by the investigator to have no impact on subject safety or trial outcomes). * History of organ transplant. * Use of any drug or food known to potently or moderately inhibit or induce cytochrome P450 3A4 enzyme (CYP3A4) and/or inhibit P-glycoprotein (P-gp) within 28 days prior to the first dose and throughout the study. * Currently participating in any other clinical study, or if received any investigational product or medical devices within ≤ 3 months or 5 half-lives (t1/2) prior to screening, whichever is longer. * Donation or loss of ≥ 400 mL of blood or transfusion/blood products during this period within 3 months prior to screening, or intention to donate blood during the study. * emale participants during pregnancy or lactation. * The investigator, site personnel, and/or their immediate family members directly related to the study. An immediate family member is defined as a spouse, parent, child, or sibling, whether biological or legally adopted. * Participants who may be unable to complete this study for other reasons, or have other conditions that, as assessed by the investigator, will make the participant unsuitable for participation in this study, for example, the participant refuses to use only the weight-loss drugs specified in the protocol during the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
45 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Central Hospital Affiliated To Shangdong First Medical University
Jinan, China
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Central Hospital of Jin zhou
Jinzhou, China
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Dongyang People's Hospital
Dongyang, China
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First Hospital of Shanxi Medical University
Taiyuan, China
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Ganzhou People's Hospital
Ganzhou, China
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Huizhou Central People's Hospital
Huizhou, China
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Huizhou Third People's Hospital
Huizhou, China
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Huzhou Central Hospital
Huzhou, China
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Jingzhou Hospital Affiliated to Yangtze University
Jinzhou, China
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JiuJiang No.1 people's Hospital
Jiujiang, China
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Lianyungang Hospital of TCM
Lianyungang, China
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Liaocheng People's Hospital
Liaocheng, China
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Loudi Central Hospital
Loudi, China
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PKUCare Luzhong Hospital
Zibo, China
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Peking University People's Hospital
Beijing, China
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People's Hospital of Hunan Province
Changsha, China
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Pingxiang People's Hospital
Pingxiang, China
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Sanya Central Hospital (Hainan Third People's Hospital)
Sanya, China
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Shanxi Bethune Hospital
Taiyuan, China
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Shenyang Fifth People Hospital
Shenyang, China
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Shenyang Sixth People's Hospital
Shenyang, China
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Siping Central People's Hospital
Siping, China
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Taizhou Hospital of Zhejiang province
Taizhou, China
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The First Affiliated Hospital of Ningbo University
Ningbo, China
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The First Affiliated Hospital of Soochow University
Suzhou, China
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The First People's Hospital of Changde City
Changde, China
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The Fourth Hospital of Changsha
Changsha, China
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The People's Hospital of liaoning Province
Shenyang, China
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The Second Affiliated Hospital of ZhengzhouUniversity
Zhengzhou, China
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The Second Hospital of Anhui Medical University
Hefei, China
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The Second Hospital of Hebei Medical University
Shijia Zhuang, China
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The Second Hospital of Jilin University
Changchun, China
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The SecondPeople's Hospital of Hefei
Hefei, China
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The Third Affiliated Hospital of Jinzhou Medical University
Jinzhou, China
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The Third People's Hospital of Datong
Datong, China
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The Third People's Hospital of Zhengzhou
Zhengzhou, China
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Wuhan Third Hospital•Tongren Hospital of Wuhan University
Wuhan, China
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Xiangya Hospital Zhuzhou Central South University
Zhuzhou, China
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Xuancheng People's Hospital
Xuancheng, China
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Yichang Central People's Hospital
Yibin, China
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Yichang Central People's Hospital
Yichang, China
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Yueyang Central Hospital
Yueyang, China
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Yueyang People's Hospital
Yueyang, China
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Zibo Central Hospital
Zibo, China
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Zibo Municipal Hospital
Zibo, China
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