A Study of MI226 Injection for Abdominal Fat Accumulation

NCT07749742 | Recruiting Phase 1

• 1 other identifier: KS20261101
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Abdominal Fat

Keywords

Abdominal Fat; MI226 Injection

Outcome Measures

Primary Outcomes (5)

• Incidence and severity of treatment-emergent adverse events (TEAEs) as assessed by NCI CTCAE v6.0

  Safety and tolerability will be evaluated by recording adverse events. AEs will be graded according to NCI CTCAE v6.0.

  Up to Day 28

• Number of participants with clinically significant abnormal physical examination findings

  Physical examination includes general appearance, skin, head and neck (eyes, ears, nose, throat), chest and lungs, cardiovascular system, abdomen, extremities, and neurological system. Clinically significant abnormalities will be recorded and summarized by system organ class.

  Up to Day 28

• Number of participants with clinically significant changes in vital signs

  Vital signs include systolic blood pressure (mmHg), diastolic blood pressure (mmHg), pulse rate (bpm), respiratory rate (breaths/min), and body temperature (°C). Clinically significant abnormalities in any of these parameters will be counted as an event.

  Up to Day 28

• Number of participants with clinically significant abnormal laboratory test results

  Laboratory examinations include hematology, serum chemistry, and urinalysis. Abnormalities will be graded according to CTCAE v6.0, and the number of participants with Grade ≥ 1 or clinically significant shifts from baseline will be summarized.

  Up to Day 7

• Number of participants with clinically significant abnormal 12-lead electrocardiogram (ECG) findings

  ECG parameters include heart rate (bpm), PR interval (msec), QRS duration (msec), and QT interval (msec). Clinically significant abnormalities will be recorded.

  Up to Day 7

Secondary Outcomes (4)

• Maximum observed plasma concentration (Cmax) of MI226

  From pre-dose to 24 hours post-dose

• Time to reach maximum observed plasma concentration (Tmax) of MI226

  From pre-dose to 24 hours post-dose

• Terminal elimination half-life (t1/2) of MI226

  From pre-dose to 24 hours post-dose

• Area under the plasma concentration-time curve from time 0 to infinity (AUC0-inf) of MI226

  From pre-dose to 24 hours post-dose

Study Arms (2)

MI226 Injection

EXPERIMENTAL

Drug: MI226 injection（dose 1）; Drug: MI226 Injection（dose 2）; Drug: MI226 Injection（dose 3）; Drug: MI226 injection（dose 4）; Drug: MI226 injection（dose 5）; Drug: MI226 Injection（dose 6）; Drug: MI226 Injection（dose 7）; Drug: MI226 injection（dose 8）

placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

MI226 injection（dose 1） DRUG

Single injection into the subcutaneous adipose tissue.

MI226 Injection

MI226 Injection（dose 2） DRUG

Single injection into the subcutaneous adipose tissue.

MI226 Injection

MI226 Injection（dose 3） DRUG

Single injection into the subcutaneous adipose tissue.

MI226 Injection

MI226 injection（dose 4） DRUG

Single injection into the subcutaneous adipose tissue.

MI226 Injection

MI226 injection（dose 5） DRUG

Single injection into the subcutaneous adipose tissue.

MI226 Injection

MI226 Injection（dose 6） DRUG

Single injection into the subcutaneous adipose tissue.

MI226 Injection

MI226 Injection（dose 7） DRUG

Single injection into the subcutaneous adipose tissue.

MI226 Injection

MI226 injection（dose 8） DRUG

Single injection into the subcutaneous adipose tissue.

MI226 Injection

Placebo DRUG

Placebo

placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Nanjing Minova Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

RECRUITING

Central Study Contacts

cuixia zhang

CONTACT

025-86667819; zhangcuixia@mnvpharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2026
• First Posted: August 6, 2026
• Study Start: July 28, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: August 6, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)