GLP-1 Peptide Atlas, by Delfa

Not yet recruitingPhase 3

A Phase III Study to Evaluate the Efficacy and Safety of MDR-001 in Adult Participants With Overweight or Obesity (MOBILE）

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Clinical Study to Evaluate the Efficacy and Safety of MDR-001 Administered Orally Over 52 Weeks in Participants With Overweight or Obesity (MOBILE)

Lead sponsor

MindRank AI Ltd

Asset

MDR-001

Oral · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

738

estimated

Study population

Obesity / overweight

Key I/E criterion

•BMI ≥28

Primary endpoints

•Body weight (%)•Percentage (%) of participants who achieve≥5% body weight reduction

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07274137

Org study IDMDR-001-CN-05

Timeline

Milestones

Study first posted2025-12-10actual

Last update posted2025-12-22actual

Study start2026-02estimated (month precision)

Primary completion2027-06estimated (month precision)

Study completion2027-07estimated (month precision)

Assets

Investigational agents

MDR-001

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

Maximum age65 Years

SexAll

Healthy volunteersNot accepted

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.

Endpoints (19)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition

Cardiometabolic biomarkers

Glycemic / diabetes

Other (unclassified)

Safety / tolerability / PK

Weight & body composition

7 endpoints

Primary/protocol endpoint

Percentage change from baseline in body weight (%) at Week 52

Time frame:baseline,Week 52

percent change from baseline, improvement

Primary/protocol endpoint

Percentage (%) of participants who achieve≥5% body weight reduction from baseline at Week 52

Time frame:baseline,Week 52

threshold achievement, improvement

Secondary/protocol endpoint

Change from baseline in body weight (kg) at Week 52

Time frame:baseline,Week 52

change from baseline, improvement

Secondary/protocol endpoint

Percentage (%) of participants who achieve ≥ 10% or ≥ 15% body weight reduction from baseline at Week 52

Time frame:Baseline,Week52

threshold achievement, improvement

Secondary/protocol endpoint

Change from baseline in BMI (kg/m2) at Week 52

Time frame:Baseline,Week52

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in waist circumference (cm) at Week 52

Time frame:Baseline, Week52

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in waist-hip ratio (%) at Week 52

Time frame:Baseline,Week52

change from baseline, improvement

Glycemic / diabetes

2 endpoints

Secondary/protocol endpoint

Change from baseline in Glycosylated hemoglobin (HbA1c, %) at Week 52

Time frame:baseline，Week 52

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in Fasting plasma glucose (FPG, mmol/L) at Week 52

Time frame:baseline，Week 52

change from baseline, improvement

Cardiometabolic biomarkers

7 endpoints

Secondary/protocol endpoint

Change from baseline in Total cholesterol (TC, mmol/L) at Week 52

Time frame:Baseline, Week 52

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in Triglycerides (TG, mmol/L) at Week 52

Time frame:baseline,Week 52

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in Low-density lipoprotein cholesterol (LDL-C, mmol/L) at Week 52

Time frame:baseline,Week 52

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in High-density lipoprotein cholesterol (HDL-C，mmol/L) at Week 52

Time frame:baseline,Week 52

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in Non-high-density lipoprotein cholesterol (nHDL-C, mmol/L) at Week 52

Time frame:baseline,Week 52

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in Systolic blood pressure (SBP, mmHg) at Week 52

Time frame:baseline，Week 52

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in Diastolic blood pressure (DBP, mmHg) at Week 52

Time frame:baseline，Week 52

change from baseline, improvement

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

Adverse events

Time frame:baseline，Week 52

descriptive

Other (unclassified)

2 endpoints

Secondary/protocol endpoint/low confidence

Change from baseline in hip circumference (cm) at Week 52

Time frame:Baseline,Week 52

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change from baseline in Lipoprotein (a) (Lp[a], mg/dL) at Week 52

Time frame:baseline，Week 52

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.