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Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IBI362 in Overweight or Obesity Subjects
Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IBI362 in Overweight or Obese Subjects
Lead sponsor
Asset
Mazdutide
Subcutaneous · GLP-1 / glucagon dual
Listed sites
1
Recruiting sites
—
Enrollment
60
actual
Study population
Obesity / overweight
Key I/E criterion
•BMI ≥24
Primary endpoint
•Treatment-emergent AEs (any)
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
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. Have stable body weight for the past 12 weeks prior to screening
2. Have a body mass index (BMI) ≥24 kilograms per meter squared (kg/m²) with complication, or BMI≥28 kg/m²,inclusive at screening
3. Willing and agreeable to commit to the duration of the study and undergo study procedures as instructed by the clinic staff
Exclusion criteria
1. Have a diagnosis of type 2 diabetes
2. Have received prescription drugs or over the counter drugs that promote weight loss in the past 3 months prior to screening
3. Previous treatment with a GLP-1 (glucagon-like peptide 1) receptor agonists or GCG(glucagon)receptor agonists before.
4. Surgical treatment for obesity
5. Past or current chronic or idiopathic pancreatitis, or any of the following: -amylase or lipase above 2 times UNR (upper normal range), triglycerides above 500 mg/dL
6. Have other medical conditions or medical history that make participation in the study unsafe or which may interfere in the interpretation of the results of the study
7. Unwilling to comply with smoking and alcohol restrictions during the study
Endpoints (9)
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
1 endpointChange in body weight from baseline
Time frame:Baseline (Day 1 ) and 12 week for groups
Body weight, absolute change (kg)
change from baseline, improvement
Glycemic / diabetes
3 endpointsEvaluate the Fasting Blood Glucose (FBG ) of IBI362 in overweight or obesity subjects;
Time frame:From the first dose (Day 1 ) of study drug until 12 week
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Evaluate the Insulin of IBI362 in overweight or obesity subjects;
Time frame:From the first dose (Day 1 ) of study drug until 12 week
descriptive
Evaluate the C-peptide of IBI362 in overweight or obesity subjects;
Time frame:From the first dose (Day 1 ) of study drug until 12 week
change from baseline, improvement
Safety / tolerability / PK
4 endpointsNumber of treatment adverse events
Time frame:From the time of first dosing (Day 1 ) until completion of the post treatment follow-up visit (20 week)
Treatment-emergent AEs (any)
event count, event
Number of Participants With Anti-IBI362 Antibodies
Time frame:From the time of first dosing (Day 1 )until comletion of the post treatment follow-up visit (20 week)
Immunogenicity (ADA)
threshold achievement, event
Evaluate the Peak Plasma Concentration (Cmax) of IBI362 in overweight or obesity subjects;
Time frame:From the first dose (Day 1 ) of study drug until 12 week
Cmax
concentration, descriptive
Evaluate the Area under the plasma concentration versus time curve (AUC) of IBI362 in overweight or obesity subjects;
Time frame:From the first dose (Day 1 ) of study drug until 12 week
AUC₀–∞
concentration, descriptive
Other (unclassified)
1 endpointEvaluate the Glucagon of IBI362 in overweight or obesity subjects;
Time frame:From the first dose (Day 1 ) of study drug until 12 week
descriptive
Publications (2)
Bibliography
Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.
Registry references + supporting bibliography
- EClinicalMedicine2022 Dec (month)PMID36247927doi:10.1016/j.eclinm.2022.101691via clinicaltrials gov reference derived + pubmed nct search
- EClinicalMedicine2021 Sep (month)PMID34430840doi:10.1016/j.eclinm.2021.101088via clinicaltrials gov reference derived + pubmed nct search
Provenance
Sources
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.