Clinical trial Recruiting at 1 site Phase 1 Interventional Ages 18 to 65

MI226 injection for abdominal fat: early safety and dosing in adults

Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of MI226 Injection in Subjects With Abdominal Fat Accumulation

Run by Nanjing Minova Pharmaceutical Co., Ltd. · NCT07749742 · Data updated 2026-11-12

This Phase 1 trial tests MI226 Injection in adults with abdominal fat buildup to see if it is safe, tolerable, and how it behaves in the body.

Quick facts

PhasePhase 1
Study typeInterventional
Ages18 Years to 65 Years
SexAll
Enrollment52 (estimated)
SponsorNanjing Minova Pharmaceutical Co., Ltd.
Industry-sponsored
Locations1 site (Beijing, Beijing Municipality)
StatusRecruiting
StartedJuly 28, 2026
Main results expectedFebruary 2027
Study endsMarch 2027
Registry record updatedAugust 6, 2026
Trial IDNCT07749742 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults aged 18–64 with measurable abdominal fat accumulation (CPnS ≥2) and willing to use contraception.

Probably not a fit

Individuals outside the age range, with BMI outside 19–37, or with contraindicating health conditions may not benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1, randomized, double-blind, placebo-controlled study with open-label sentinel cohorts to evaluate the safety, tolerability, and pharmacokinetics of a single subcutaneous MI226 Injection across 8 dose groups. About 52 participants will receive escalating doses from 24 mg to 1200 mg, with sentinel cohorts initially receiving active treatment. The study includes PK blood sampling, ECG monitoring, and safety follow-up for 28 days after dosing. Dose escalation depends on 7-day safety data and predefined stopping criteria. Primary aims focus on safety and PK, while a secondary aim looks at QT/QTc effects in later cohorts.

Why it matters

Potential benefit: If successful, MI226 could become a new option for managing abdominal fat by providing a targeted pharmacologic approach.

How similar studies have gone: Prior early-phase studies of similar injections have shown acceptable safety in small cohorts, but this exact approach is in early development.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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's running

  • Peking Union Medical College Hospital
    Beijing, Beijing Municipality, China
    Recruiting

Study contacts

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.