GLP-1 Peptide Atlas, by Delfa

RecruitingPhase 1, PHASE2

A Phase I/IIa Clinical Study to Assess the Single and Multiple Ascending Doses of MDR-001 Tablets in Healthy Participants and Obese/ Overweight Participants

A Randomized, Double-blind, Placebo-controlled Phase I/IIa Clinical Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Doses of MDR-001 Tablets Administrated Orally in Healthy Participants and Obese/ Overweight Participants

Lead sponsor

MindRank AI Ltd

Asset

MDR-001

Oral · GLP-1 agonist

Listed sites

Recruiting sites

Enrollment

131

estimated

Study population

Healthy volunteers, Obesity / overweight

Key I/E criterion

•BMI ≤45

Primary endpoint

•One or More Treatment Emergent Adverse Events (TEAEs)

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 IDNCT06778850

Org study IDMDR-001-CN-01

Timeline

Milestones

Study start2023-06-09actual

Study first posted2025-01-16actual

Last update posted2025-03-07actual

Primary completion2025-07-15estimated

Study completion2025-12-30estimated

Assets

Investigational agents

MDR-001

Study populations

Who this study enrolls

Healthy volunteersObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

Maximum age55 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Participants who are aged ≥ 18 and ≤ 55 years at the time of signing the informed consent; no gender restriction.

•Participants with 27 ≤ body mass index (BMI) ≤ 45 kg/m2.

•For male participants, a waist circumference ≥ 90 cm is required, while female participants ≥ 85 cm.

Exclusion criteria

•Participants with any condition that increases the risk of bleeding, such as hemorrhoids, acute gastritis, or gastric and duodenal ulcers.

•Participants with personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia 2 (MEN2), or those with hereditary diseases that easily induce to medullary thyroid carcinoma.

•Participants with a history of pancreatitis or symptomatic gallbladder disease.

•Serum calcitonin > ULN at screening.

•Participants with systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg at screening.

•Participants with ALT >2 × ULN and /or AST > 2 × ULN at screening.

•Participants whose fasting triglycerides > 5.7 mmol/L, total cholesterol > 7.75 mmol/L, low-density lipoprotein cholesterol > 4.9 mmol/L at screening.

•Participants with abnormal uric acid levels accompanied by clinical symptoms (those without clinical symptoms can be included).

•Participants with fasting blood glucose levels > 7 mmol/L.

•Participants with creatinine clearance < 60 mL/min at screening [calculation formula: CLcr: (140 - age) × weight (kg) / [72 × 0.0113 × Scr (μmol/L)], × 0.85 for females].

•Participants have experienced significant changes in diet or exercise habits or within ≥5% changes in body weight within 3 months prior to screening.

•Participants with clinically significant ECG abnormality deemed unsuitable participation for study by the investigator; or with ECG QTcF values > 450 ms for male participants or > 470 ms for female participants.

Endpoints (6)

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

Safety / tolerability / PK

Glycemic / diabetes

Weight & body composition

1 endpoint

Secondary/protocol endpoint

Change from Baseline in Body Weight