GLP-1 Peptide Atlas, by Delfa

Active not recruitingPhase 1, PHASE2

Tolerance and Pharmacokinetic/Pharmacokinetic Study of IBI362 15mg in Patients With Moderate to Severe Obesity

Tolerance and Pharmacokinetic/Pharmacokinetic Study of IBI362 15mg Administered Multiple Times in Chinese Patients With Moderate to Severe Obesity

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Assets

Mazdutide / Tirzepatide

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Obesity / overweight

Key I/E criterion

•BMI ≥32.5

Primary endpoints

•Serious AEs (any) (Treatment-emergent AEs (any), Serious AEs (any))•Suicidal ideation and behavior of subjects•Incidence rates of Adverse Event of Special Interest

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 IDNCT07000955

Org study IDCIBI362B104

Timeline

Milestones

Study first posted2025-06-03actual

Study start2025-06-17actual

Last update posted2025-12-15actual

Primary completion2026-09-30estimated

Study completion2027-05-14estimated

Assets

Investigational agents

Mazdutide Tirzepatide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

Maximum age55 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•1. The age at the time of screening is 18 to 55 years old (including both ends), male or female;

•2. BMI≥32.5 kg/m2 during screening;

•3. At the time of screening, after simple diet and exercise control for at least 12 weeks, the weight change was less than 5% [(Maximum weight within 3 months before screening - minimum weight within 3 months before screening)/maximum weight within 3 months before screening ×100%, self-reported by the subjects]

•4. Fertile subjects agreed to take the contraceptive measures stipulated in this protocol throughout the study and within 3 months after the last treatment. Female subjects with reproductive capacity must have negative pregnancy test results during screening. Female subjects should not breastfeed throughout the study and within 3 months after the last treatment;

•5. Voluntarily sign the informed consent form and be willing to strictly abide by the requirements and restrictions in the informed consent form and protocol throughout the research period, including but not limited to: diet, exercise, lifestyle management, planned injection of research drugs, keeping research diaries, and completing relevant questionnaires, etc;

Exclusion criteria

•1. The investigator suspected that the subjects might be allergic to the study drug or component or have an allergic constitution;

•2. Use any of the following drugs or treatments within 3 months before screening including but not limited to GLP-1R, GIPR, GCGR, any drugs, Chinese herbal medicines, health supplements or meal replacements that have an impact on body weight, or participated in other clinical trials;

•3. There is a history or evidence of any of the following diseases before screening or at the time of screening including but not limited to diabetes, have received or plan to undergo bariatric surgery during the research period in the past, with retinopathy in the past or at the time of screening, secondary diseases or drugs lead to obesity, have a history of depression in the past or have a history of serious mental illness in the past, hypertension that has not been stably controlled at the time of screening after at least 4 weeks of antihypertensive drug treatment, a history of malignant tumors was present during the screening, heart disease, A 2A or 2B history or family history of medullary thyroid carcinoma and multiple endocrine adenomatosis (MEN) , history of acute and chronic pancreatitis, limb deformity or disability, have a history of suicidal tendencies or suicidal behaviors, etc according to the protocol.

•4. Any of the laboratory examination indicators meets the following standards during screening: serum calcitonin ≥20ng/L during screening, alanine aminotransferase ≥2.0×ULN and/or aspartate aminotransferase ≥2.0×ULN and/or total bilirubin ≥1.5×ULN and/or alkaline phosphatase ≥2.0×ULN, eGFR is less than 60 Ml/min/1.73 m2, abnormal thyroid function including FT3, FT4, or TSH, fasting triglycerides ≥5.64 mmol/L (500 mg/dl), blood amylase or lipase 1.0 x ULN;

•5. During the screening, the 12-lead electrocardiogram showed a heart rate of <50 beats per minute or >90 beats per minute;

•6. There were clinically significant ECGs abnormalities during the screening;

•7. History of other risk factors for tachycardia;

•8. The blood donation volume and/or blood loss volume within 3 months prior to screening is ≥400mL, or bone marrow donation has been performed, or there are anemia-related diseases such as hemoglobinopathy, hemolytic anemia, sickle cell anemia, etc., or hemoglobin.. 110g/ L (male) or 100g/L (females).

•9. The investigators believe that the subjects have any other factors that may affect the efficacy or safety evaluation of this study and are not suitable to participate in this study.

Endpoints (22)

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

Safety / tolerability / PK

Glycemic / diabetes

Cardiometabolic biomarkers

MASH / liver

Weight & body composition

7 endpoints

Secondary/protocol endpoint

The change in body weight from baseline

Time frame:week 44

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

The change in waist circumference from baseline

Time frame:week 44

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Changes and percentage changes of abdominal visceral fat (VAT) content, abdominal subcutaneous fat (SAT) content, and abdominal total fat (TAAT) content relative to the baseline

Time frame:week 44

Visceral fat, change

change from baseline, improvement

Secondary/protocol endpoint

The change in body-mass index from baseline

Time frame:week 44

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

The change in neck circumference from baseline

Time frame:week 44

change from baseline, improvement

Secondary/protocol endpoint

The change in hip circumference from baseline

Time frame:week 44

change from baseline, improvement

Secondary/protocol endpoint

The change in waist circumference/hip circumference ratio from baseline

Time frame:week 44

change from baseline, improvement

Glycemic / diabetes

5 endpoints

Secondary/protocol endpoint

The changes in insulin resistance index (HOMA2-IR) and islet β-cell function index (HOMA2-B) from baseline calculated by the concentration of fasting blood glucose and the concentration of fasting insulin

Time frame:week 44

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Secondary/protocol endpoint

Changes in hemoglobin A1c (HbA1c%) , from baseline

Time frame:week 44

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Changes in fasting blood glucose , from baseline

Time frame:week 44

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint/low confidence

Changes in Fasting insulin, from baseline

Time frame:week 44

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Changes in Fasting C-peptide, from baseline

Time frame:week 44

change from baseline, improvement

MASH / liver

1 endpoint

Secondary/protocol endpoint

Changes and percentage changes of liver fat content compared with the baseline

Time frame:week 44

Liver fat content, change

change from baseline, improvement

Cardiometabolic biomarkers

2 endpoints

Primary/protocol endpoint

The value of systolic and diastolic pressures

Time frame:week 44

descriptive, improvement

Primary/protocol endpoint

The value of pulse rate

Time frame:week 44

Heart rate, change

change from baseline, improvement

Safety / tolerability / PK

7 endpoints

Primary/protocol endpoint

The Incidence of adverse events and serious adverse events during the treatment period

Time frame:week 44

Serious AEs (any)

event count, event

componentsTreatment-emergent AEs (any), Serious AEs (any)

Primary/protocol endpoint

The suicidal ideation and behavior of subjects evaluated by Columbia-Suicide Severity Rating Scale (C-SSRS)

Time frame:week 44

descriptive, event

Primary/protocol endpoint

The incidence rates of Adverse Event of Special Interest

Time frame:week 44

event count, event

Primary/protocol endpoint

The RR interval, PR interval, heart rate, QT interval, Fridericia-corrected QT interval, and any abnormal reporting results of 12-lead electrocardiogram

Time frame:week 44

descriptive

Primary/protocol endpoint

Any adverse event evaluated by laboratory examinations

Time frame:week 44

descriptive, event

Secondary/protocol endpoint

Evaluate the pharmacokinetic (PK) characteristics of IBI362

Time frame:week 44

Cmax

concentration, descriptive

Secondary/protocol endpoint

Immunogenicity

Time frame:week 44

Immunogenicity (ADA)

event count, event

componentsImmunogenicity (ADA)

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.