A Study of MI226 Injection for Abdominal Fat Accumulation

Recruiting now · Phase 1 · Has a placebo group

Conditions studied: Abdominal Fat

In brief

This is a Phase 1, randomized, double-blind (with open-label sentinel cohorts), placebo-controlled, single-ascending-dose study designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of MI226 Injection in participants with abdominal fat accumulation.

Key facts

Study ID: NCT07749742
Run by: Nanjing Minova Pharmaceutical Co., Ltd.
People needed: 52
Starts: 2026-07-28
Expected to finish: 2027-03-01
Last updated by the study team: 2026-08-06

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Aged ≥18 and <65 years at the time of screening.
Male body weight ≥50 kg, female body weight ≥45 kg, and body mass index (BMI) between 19.0 kg/m² and 37.0 kg/m² (inclusive).
Presence of clinically appreciable abdominal fat accumulation, as assessed by the Clinical Photonumeric Rating Scale (CPnS) with a score of ≥2, and judged by the investigator as sufficient to accommodate the planned number of injections per assigned cohort.
Willingness to use effective contraceptive measures and to refrain from sperm/egg donation from the screening period until 3 months after the last dose of study drug; and no pregnancy plan during this period.
Ability to understand and voluntarily participate in the study, agree to comply with all study requirements, and provide written informed consent prior to any study-related procedures.

You may not qualify if…

Presence of any medical or physical condition that, in the judgment of the investigator, may interfere with the evaluation of efficacy or safety (e.g., uncontrolled hypertension, and respiratory, cardiovascular, hepatic, neurological, or thyroid diseases).
Presence of adipose tissue volume deficiency (e.g., post-traumatic) or immune-mediated lipodystrophy syndromes, including: generalized lipodystrophy (e.g., juvenile dermatomyositis-associated), partial lipodystrophy (e.g., Barraquer-Simons syndrome), or HIV-associated lipodystrophy.
History of or current clinically relevant skin disease that, in the judgment of the investigator, may affect the assessment of the injection site, or presence of keloid tendency (history of predisposition to hypertrophic scarring or keloid formation).
History of hypersensitivity (allergy to at least 2 substances) or known allergy to any component of the study drug.
Serious medical or psychiatric illness that, in the judgment of the investigator, may affect the study results or compromise participant compliance.
Restricted mobility, history of deep vein thrombosis or pulmonary embolism, or major surgery (within the past 3 months), or long-term hospitalization.
Known bleeding disorders, or use of medications that may increase the risk of post-injection bleeding (e.g., anticoagulant or antiplatelet therapy that cannot be safely discontinued) within 4 weeks prior to screening.
Females of childbearing potential who are pregnant, lactating, planning to become pregnant, or not using reliable contraceptive measures, and who are unwilling to use reliable contraception during the study (e.g., transdermal patches, intrauterine device/system [IUD/IUS], condoms, abstinence, or partner vasectomy).
Any other condition that, in the investigator's opinion, may significantly increase the participant's risk, confound the study results, or substantially interfere with the participant's participation in the study.

Where it is running

Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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