Abdominal FatPhase 1NCT07749742
A Study of MI226 Injection for Abdominal Fat Accumulation
A Phase 1 study testing MI226 injection（dose 1）, MI226 Injection（dose 2） and MI226 Injection（dose 3） in people with Abdominal Fat, run by Nanjing Minova Pharmaceutical Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Abdominal Fat
- What is being tested?
- MI226 injection（dose 1）, MI226 Injection（dose 2） and MI226 Injection（dose 3）
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteChina
- Study dates
- 28 Jul 2026to Mar 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality
About this study
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
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.
Read the detailed description
The study will enroll approximately 52 participants across 8 dose cohorts (24 mg to 1200 mg). The first two cohorts (24 mg and 60 mg) are open-label sentinel groups (2 participants each, all receiving active drug). Cohorts 3-8 are double-blind with a 6:1 or 8:1 randomization ratio to MI226 Injection or placebo. Each participant receives a single subcutaneous abdominal injection (0.2 mL per injection point, 1 cm apart, total volume up to 20 mL). The primary objectives are to assess the safety/tolerability and PK profile of MI226. Secondary objective is to evaluate the effect of MI226 on QT/QTc interval using a concentration-QTc (C-QTc) model in cohorts 5-8. Participants are followed for 28 days post-dose with serial safety assessments, PK blood sampling (13 time points over 24 hours for cohorts 3-8), and ECG monitoring. Dose escalation proceeds after review of 7-day safety data from the preceding cohort, with predefined stopping criteria.
- Conditions
- Abdominal Fat
- Being tested
- MI226 injection（dose 1）, MI226 Injection（dose 2）, MI226 Injection（dose 3）, MI226 injection（dose 4）, MI226 injection（dose 5）
- Keywords
- Abdominal Fat, MI226 Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MI226 injection（dose 1）Drug
Single injection into the subcutaneous adipose tissue.
MI226 Injection（dose 2）Drug
Single injection into the subcutaneous adipose tissue.
MI226 Injection（dose 3）Drug
Single injection into the subcutaneous adipose tissue.
MI226 injection（dose 4）Drug
Single injection into the subcutaneous adipose tissue.
MI226 injection（dose 5）Drug
Single injection into the subcutaneous adipose tissue.
MI226 Injection（dose 6）Drug
Single injection into the subcutaneous adipose tissue.
MI226 Injection（dose 7）Drug
Single injection into the subcutaneous adipose tissue.
MI226 injection（dose 8）Drug
Single injection into the subcutaneous adipose tissue.
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| MI226 Injection | Experimental | Not described Receives: 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 | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to Day 7
Secondary outcomes (4)
Maximum observed plasma concentration (Cmax) of MI226
Plasma concentrations of MI226 will be measured using a validated LC-MS/MS method. Cmax will be derived using non-compartmental analysis.
Measured: From pre-dose to 24 hours post-dose
Time to reach maximum observed plasma concentration (Tmax) of MI226
Plasma concentrations of MI226 will be measured using a validated LC-MS/MS method.
Measured: From pre-dose to 24 hours post-dose
Terminal elimination half-life (t1/2) of MI226
Plasma concentrations of MI226 will be measured using a validated LC-MS/MS method.
Measured: From pre-dose to 24 hours post-dose
Area under the plasma concentration-time curve from time 0 to infinity (AUC0-inf) of MI226
Plasma concentrations of MI226 will be measured using a validated LC-MS/MS method. AUC0-inf will be derived using non-compartmental analysis.
Measured: From pre-dose to 24 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study start28 Jul 2026
- Primary completionFeb 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal FatStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Minova Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07749742
- Sponsor's protocol ID
- KS20261101
- Status last verified
- Jul 2026
- First submitted
- 19 Jul 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07749742
- Acronym / sponsor ID
- KS20261101
- Conditions
- Abdominal Fat
- Keywords
- Abdominal Fat, MI226 Injection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Nanjing Minova Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Jul 2026 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 6 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study will enroll approximately 52 participants across 8 dose cohorts (24 mg to 1200 mg). The first two cohorts (24 mg and 60 mg) are open-label sentinel groups (2 participants each, all receiving active drug). Cohorts 3-8 are double-blind with a 6:1 or 8:1 randomization ratio to MI226 Injection or placebo. Each participant receives a single subcutaneous abdominal injection (0.2 mL per injection point, 1 cm apart, total volume up to 20 mL). The primary objectives are to assess the safety/tolerability and PK profile of MI226. Secondary objective is to evaluate the effect of MI226 on QT/QTc interval using a concentration-QTc (C-QTc) model in cohorts 5-8. Participants are followed for 28 days post-dose with serial safety assessments, PK blood sampling (13 time points over 24 hours for cohorts 3-8), and ECG monitoring. Dose escalation proceeds after review of 7-day safety data from the preceding cohort, with predefined stopping criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MI226 injection（dose 1）Single injection into the subcutaneous adipose tissue. | Drug | MI226 Injection |
| MI226 Injection（dose 2）Single injection into the subcutaneous adipose tissue. | Drug | MI226 Injection |
| MI226 Injection（dose 3）Single injection into the subcutaneous adipose tissue. | Drug | MI226 Injection |
| MI226 injection（dose 4）Single injection into the subcutaneous adipose tissue. | Drug | MI226 Injection |
| MI226 injection（dose 5）Single injection into the subcutaneous adipose tissue. | Drug | MI226 Injection |
| MI226 Injection（dose 6）Single injection into the subcutaneous adipose tissue. | Drug | MI226 Injection |
| MI226 Injection（dose 7）Single injection into the subcutaneous adipose tissue. | Drug | MI226 Injection |
| MI226 injection（dose 8）Single injection into the subcutaneous adipose tissue. | Drug | MI226 Injection |
| PlaceboPlacebo | Drug | placebo |
Primary outcome
Incidence and severity of treatment-emergent adverse events (TEAEs) as assessed by NCI CTCAE v6.0
Time frame: Up to Day 28
Safety and tolerability will be evaluated by recording adverse events. AEs will be graded according to NCI CTCAE v6.0.
Number of participants with clinically significant abnormal physical examination findings
Time frame: Up to Day 28
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.
Number of participants with clinically significant changes in vital signs
Time frame: Up to Day 28
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.
Number of participants with clinically significant abnormal laboratory test results
Time frame: Up to Day 7
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.
Number of participants with clinically significant abnormal 12-lead electrocardiogram (ECG) findings
Time frame: Up to Day 7
ECG parameters include heart rate (bpm), PR interval (msec), QRS duration (msec), and QT interval (msec). Clinically significant abnormalities will be recorded.
4 secondary outcomes
Maximum observed plasma concentration (Cmax) of MI226
Time frame: From pre-dose to 24 hours post-dose
Time to reach maximum observed plasma concentration (Tmax) of MI226
Time frame: From pre-dose to 24 hours post-dose
Terminal elimination half-life (t1/2) of MI226
Time frame: From pre-dose to 24 hours post-dose
Area under the plasma concentration-time curve from time 0 to infinity (AUC0-inf) of MI226
Time frame: From pre-dose to 24 hours post-dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MI226 injection（dose 1）, MI226 Injection（dose 2） and MI226 Injection（dose 3） in people with Abdominal Fat, run by Nanjing Minova Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact cuixia zhang (025-86667819 ext. 833, zhangcuixia@mnvpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of treatment-emergent adverse events (TEAEs) as assessed by NCI CTCAE v6.0 (time frame: Up to Day 28). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.