Androgenetic AlopeciaPhase 2NCT06118866

A Study to Assess the Efficacy and Safety of HMI-115 in Male Subjects With Androgenetic Alopecia

A Phase 2 study testing HMI-115-120mg-Q4W, HMI-115-240mg-Q4W and HMI-115, 240mg-Q2W in people with Androgenetic Alopecia, run by Hope Medicine (Nanjing) Co., Ltd at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To investigate the efficacy of HMI-115 compared to placebo in treating Androgenic Alopecia patients for 24 weeks Read more about this study

Who is it for?: Ages 18 to 65 years, men only
Conditions the study is for: Androgenetic Alopecia
What is being tested?: HMI-115-120mg-Q4W, HMI-115-240mg-Q4W and HMI-115, 240mg-Q2W
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 192 participants
Where: 1 siteChina
Study dates: 11 Sep 2023to 28 Nov 2024
Phase: Phase 2
Are there results?: None posted in the registry

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
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects.
Male subjects, between 18 and 65 years of age, inclusive, at the time of signing informed consent.
Clinical diagnosis of androgenetic alopecia. Male subjects who meet Norwood-Hamilton scales III vertex, IV and V .
Be willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions, including having a small circle about 1 cm2 of hair clipped to approximate 1 mm in length and micro-dot-tattoo on the scalp of target area.
Subjects who are willing to keep the same hair color, refrain from hair weaving, and hair growth therapy and supplement (except for protocol specified IMP) during the study.
Subjects agree to use required birth control methods from signing the consent until 3 months after the last dose of IMP or complete whole study period whichever is longer.

Who cannot join

Subject with history of scalp radiation or surgery which could interfere study assessment (e.g., hair transplantation surgery).
Subject with history of scalp laser treatment within 6 months prior screening, including but not limited to, low level laser, and fractional laser, etc.
Subject with history of hair weaves within 3 months prior screening.
Subject has a current history of hyperthyroidism or uncontrolled hypothyroidism.
Subject has, in the Investigator's opinion, uncontrolled hypertension (systolic blood pressure [SBP] > 159 mmHg, diastolic blood pressure [DBP] > 99 mmHg).
Subject has any of the following conditions within 6 weeks prior to Screening:

Show all 11Show fewer

Myocardial infarction, stroke, unstable angina, or transient ischemic attack.
Heart failure with classified as being in New York Heart Association Class III or IV.
Subject has high fever, major surgery, or ten percent or more weight decrease within three months before screening.
Subject with history of active malignancy (with or without systemic chemotherapy), except treated basal cell carcinoma of the skin (besides scalp).
Subject plans to schedule elective surgery during the study.

Trial locations and contacts

1 site in 1 country.

China1 site

Peking University People's Hospital
Beijing, Beijing Municipality, 100035

Other trials in China

About this study

Official title: A Randomized, Multicenter, Double-blind, Placebo-Controlled Phase 2 Study to Evaluate the Safety, Tolerability and Efficacy in Male Androgenetic Alopecia Treated With HMI-115 Over a 24-Week Treatment Period

To investigate the efficacy of HMI-115 compared to placebo in treating Androgenic Alopecia patients for 24 weeks

Conditions: Androgenetic Alopecia
Being tested: placebo-Q2W, HMI-115-120mg-Q4W, HMI-115-240mg-Q4W, HMI-115, 240mg-Q2W
Medical subject headings: Alopecia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

placebo-Q2WDrug
placebo, 0mg，SC，Q2W，12 cycles
HMI-115-120mg-Q4WDrug
HMI-115, 120mg，SC，Q4W，6 cycles(Placebo given in the second week of each cycle)
HMI-115-240mg-Q4WDrug
HMI-115, 240mg，SC，Q4W，6 cycles(Placebo given in the second week of each cycle)
HMI-115, 240mg-Q2WDrug
HMI-115, 240mg，SC，Q2W，12 cycles

Study groups in NCT06118866
Study group	Role	What they receive
placebo-Q2W	Placebo comparator	placebo, 0mg/vials Receives: Drug: placebo-Q2W
HMI-115-120mg-Q4W	Active comparator	HMI-115, 60mg/vials Receives: Drug: HMI-115-120mg-Q4W
HMI-115-240mg-Q4W	Active comparator	HMI-115, 60mg/vials Receives: Drug: HMI-115-240mg-Q4W
HMI-115-240mg-Q2W	Active comparator	HMI-115, 60mg/vials Receives: Drug: HMI-115, 240mg-Q2W

What is being measured

The primary outcome is the main question the study is designed to answer.

The Rate of Target Arean Hair Count (TAHC)
The mean change in TAHC of non-vellus from baseline
Measured: 24 Weeks

Secondary outcomes (19)

Hair Growth State Assessed by Hair Growth Questionnaire Assessment (HGQA)
To assess the hair growth by 7-question questionnaire and summary the number and percentage of subjects in each category for each HGQA question.
Measured: 6 weeks, 12 weeks, 18 weeks, 24 weeks, and 36 weeks
Target Area Hair Count (TAHC) change from baseline
The mean change in TAHC of non-vellus from Baseline
Measured: 6 weeks, 12 weeks, 18 weeks, 24 weeks, and 36 weeks
Rate of Target Area Hair Width (TAHW)
The mean change in TAHW of non-vellus from baseline
Measured: 6 weeks, 12 weeks, 18 weeks, 24 weeks, and 36 weeks
Investigator Global Assessment (IGA)
Summary of subject number and percentage in each IGA category
Measured: 6 weeks, 12 weeks, 18 weeks, 24 weeks, and 36 weeks
Subject Self-Assessment (SSA)
Summary of subject number and percentage in each SSA category
Measured: 6 weeks, 12 weeks, 18 weeks, 24 weeks, and 36 weeks
Norwood-Hamilton Grade change from baseline
Summary of subject number and percentage in each grade of Norwood-Hamilton Scale
Measured: 12 weeks, 24 weeks, and 36 weeks
Frequencies and percentages of Adverse event (AE)
Frequency and percentages of subjects with treatment-emergent AE (TEAE) will be calculated and TEAE will be summarized by systematic organ classification (SOC), preferred term (PT), relationship to study treatment, maximum severity, whether resulting in death, whether resulting in study treatment discontinuation, belong to serious AE (SAE) or not, belong to events of special interest (AESI) or not.
Measured: 36Weeks
Blood Pressure change from baseline
Descriptive statistics summarizing changes in blood pressure (systolic and diastolic) will be compared between baseline levels and each predetermined time point.
Measured: 36 Weeks
Pulse change from baseline
Descriptive statistics summarizing changes in pulse will be compared between baseline levels and each predetermined time point.
Measured: 36 Weeks
Body temperature change from baseline
Descriptive statistics summarizing changes in body temperature will be compared between baseline levels and each predetermined time point.
Measured: 36 Weeks
Respiratory rate
Descriptive statistics summarizing changes in respiratory rate will be compared between baseline levels and each predetermined time point.
Measured: 36 Weeks
Complete or brief physical examination, at a minimum of General appearance, HEENT (head, eyes, ears, nose, throat), Neck, Lung/pulmonary, Chest, Neurological or not, Extremities,ect.to assess the physical health state.
Physical examination findings by body system will be summarized, presented with frequency counts and percentages. A complete or brief physical examination will be performed at Visit 1, Visit 2, End of Treatment Visit and Follow-up Visit. Height (cm) and weight (kg) will be measured and body mass index will be calculated and recorded at specified period.
Measured: 36 Weeks
Concomitant Medication
Concomitant medication usage will be summarized by the number and proportion of subjects and classified by the World Health Organization Drug Dictionary (WHO DD) based on Anatomical Therapeutic Chemical Classification System (ATC) code level 3.
Measured: 36 Weeks
Change in twelve-lead electrocardiogram parameters
Change in electrocardiogram parameters including heart rate (HR), QRS, RR, PR, and QT interval (QTcF and QTcB) relative to baseline will be summarized descriptively by visits and groups. The within-group changes from baseline to each visit will be summarized and will be compared with a paired t-test for continuous measurements. Subject number and percentage with other clinically significant electrocardiogram findings in each visit will be summarized by groups. A general assessment of the 12-lead electrocardiogram will be presented as normal, abnormal clinical significance, or abnormal no clinical significance.
Measured: 36 Weeks
Clinical laboratory tests of hematology
Descriptive statistics summarizing changes in results of clinical laboratory tests of hematology from baseline levels at each predetermined time point. Shift tables for changes from baseline according to the normal minimum and maximum will be provided.
Measured: 36 Weeks
Clinical laboratory tests of coagulation
Descriptive statistics summarizing changes in results of clinical laboratory tests of coagulation from baseline levels at each predetermined time point. Shift tables for changes from baseline according to the normal minimum and maximum will be provided.
Measured: 36 Weeks
Clinical laboratory tests of clinical chemistry
Descriptive statistics summarizing changes in results of clinical laboratory tests of clinical chemistry from baseline levels at each predetermined time point. Shift tables for changes from baseline according to the normal minimum and maximum will be provided.
Measured: 36 Weeks
Clinical laboratory tests of urinalysis
Descriptive statistics summarizing changes in results of clinical laboratory tests of urinalysis from baseline levels at each predetermined time point. Shift tables for changes from baseline according to the normal minimum and maximum will be provided.
Measured: 36 Weeks
Clinical laboratory tests of hormones
Descriptive statistics summarizing changes in results of clinical laboratory tests of hormones from baseline levels at each predetermined time point. Shift tables for changes from baseline according to the normal minimum and maximum will be provided.
Measured: 36 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Sep 202328 Nov 2024

First posted7 Nov 2023
Study start11 Sep 2023
Primary completion26 Aug 2024
Study completion28 Nov 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Androgenetic AlopeciaStudies 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 192 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06118866
Sponsor's protocol ID: HMI-115AG201
Status last verified: Jun 2025
First submitted: 16 Oct 2023
Last updated: 4 Jun 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 2
Phase 2 Efficacy and Safety of PP405 in Adult Females With Androgenetic Alopecia
Androgenetic Alopecia
Not yet recruitingPhase 3
Phase 3 Study to Evaluate the Efficacy and Safety of Oral Minoxidil (N1087) in Men With Androgenetic Alopecia.
Androgenetic Alopecia, Androgenetic Alopecia (AGA)
Not yet recruiting
Study to Evaluate Xtressé Gummy Supplement in Women With Thinning Hair
Androgenetic Alopecia
Not yet recruitingEarly Phase 1
Evaluating the Efficacy of Platelet-rich Plasma Therapy in the Treatment of Androgenic Alopecia
Androgenic Alopecia
Not yet recruitingPhase 3
Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of N1087 in Participants With Female Pattern Hair Loss (MINORA-WOMEN)
Female Pattern Hair Loss, Female Pattern Hair Loss, Androgenic Alopecia

All Androgenetic Alopecia trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Multicenter, Double-blind, Placebo-Controlled Phase 2 Study to Evaluate the Safety, Tolerability and Efficacy in Male Androgenetic Alopecia Treated With HMI-115 Over a 24-Week Treatment Period
ClinicalTrials.gov ID: NCT06118866
Acronym / sponsor ID: HMI-115AG201
Conditions: Androgenetic Alopecia
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 192 participants (actual)
Lead sponsor: Hope Medicine (Nanjing) Co., LtdIndustry (pharma, biotech, devices)
Study start: 11 Sep 2023 (actual)
Primary completion: 26 Aug 2024 (actual)
Study completion: 28 Nov 2024 (actual)
First posted: 7 Nov 2023 (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.

To investigate the efficacy of HMI-115 compared to placebo in treating Androgenic Alopecia patients for 24 weeks

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
placebo-Q2W	Placebo comparator	Drug: placebo-Q2Wplacebo, 0mg/vials
HMI-115-120mg-Q4W	Active comparator	Drug: HMI-115-120mg-Q4WHMI-115, 60mg/vials
HMI-115-240mg-Q4W	Active comparator	Drug: HMI-115-240mg-Q4WHMI-115, 60mg/vials
HMI-115-240mg-Q2W	Active comparator	Drug: HMI-115, 240mg-Q2WHMI-115, 60mg/vials

Who may qualify

Ages: 18 to 65 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects.
Male subjects, between 18 and 65 years of age, inclusive, at the time of signing informed consent.
Clinical diagnosis of androgenetic alopecia. Male subjects who meet Norwood-Hamilton scales III vertex, IV and V .
Be willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions, including having a small circle about 1 cm2 of hair clipped to approximate 1 mm in length and micro-dot-tattoo on the scalp of target area.
Subjects who are willing to keep the same hair color, refrain from hair weaving, and hair growth therapy and supplement (except for protocol specified IMP) during the study.

Key exclusion criteria (11 listed)

Subject with history of scalp radiation or surgery which could interfere study assessment (e.g., hair transplantation surgery).
Subject with history of scalp laser treatment within 6 months prior screening, including but not limited to, low level laser, and fractional laser, etc.
Subject with history of hair weaves within 3 months prior screening.
Subject has a current history of hyperthyroidism or uncontrolled hypothyroidism.
Subject has, in the Investigator's opinion, uncontrolled hypertension (systolic blood pressure [SBP] > 159 mmHg, diastolic blood pressure [DBP] > 99 mmHg).

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
placebo-Q2Wplacebo, 0mg，SC，Q2W，12 cycles	Drug	placebo-Q2W
HMI-115-120mg-Q4WHMI-115, 120mg，SC，Q4W，6 cycles(Placebo given in the second week of each cycle)	Drug	HMI-115-120mg-Q4W
HMI-115-240mg-Q4WHMI-115, 240mg，SC，Q4W，6 cycles(Placebo given in the second week of each cycle)	Drug	HMI-115-240mg-Q4W
HMI-115, 240mg-Q2WHMI-115, 240mg，SC，Q2W，12 cycles	Drug	HMI-115-240mg-Q2W

Primary outcome

The Rate of Target Arean Hair Count (TAHC)
Time frame: 24 Weeks
The mean change in TAHC of non-vellus from baseline

19 secondary outcomes

Hair Growth State Assessed by Hair Growth Questionnaire Assessment (HGQA)
Time frame: 6 weeks, 12 weeks, 18 weeks, 24 weeks, and 36 weeks
Target Area Hair Count (TAHC) change from baseline
Time frame: 6 weeks, 12 weeks, 18 weeks, 24 weeks, and 36 weeks
Rate of Target Area Hair Width (TAHW)
Time frame: 6 weeks, 12 weeks, 18 weeks, 24 weeks, and 36 weeks
Investigator Global Assessment (IGA)
Time frame: 6 weeks, 12 weeks, 18 weeks, 24 weeks, and 36 weeks
Subject Self-Assessment (SSA)
Time frame: 6 weeks, 12 weeks, 18 weeks, 24 weeks, and 36 weeks
Norwood-Hamilton Grade change from baseline
Time frame: 12 weeks, 24 weeks, and 36 weeks
Frequencies and percentages of Adverse event (AE)
Time frame: 36Weeks
Blood Pressure change from baseline
Time frame: 36 Weeks
Pulse change from baseline
Time frame: 36 Weeks
Body temperature change from baseline
Time frame: 36 Weeks
Respiratory rate
Time frame: 36 Weeks
Complete or brief physical examination, at a minimum of General appearance, HEENT (head, eyes, ears, nose, throat), Neck, Lung/pulmonary, Chest, Neurological or not, Extremities,ect.to assess the physical health state.
Time frame: 36 Weeks
Concomitant Medication
Time frame: 36 Weeks
Change in twelve-lead electrocardiogram parameters
Time frame: 36 Weeks
Clinical laboratory tests of hematology
Time frame: 36 Weeks
Clinical laboratory tests of coagulation
Time frame: 36 Weeks
Clinical laboratory tests of clinical chemistry
Time frame: 36 Weeks
Clinical laboratory tests of urinalysis
Time frame: 36 Weeks
Clinical laboratory tests of hormones
Time frame: 36 Weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
Individual participant dataSharing planned: No

Related trials for Androgenetic Alopecia

Not yet recruitingPhase 2
Phase 2 Efficacy and Safety of PP405 in Adult Females With Androgenetic Alopecia
Androgenetic Alopecia
Not yet recruitingPhase 3
Phase 3 Study to Evaluate the Efficacy and Safety of Oral Minoxidil (N1087) in Men With Androgenetic Alopecia.
Androgenetic Alopecia, Androgenetic Alopecia (AGA)
Not yet recruiting
Study to Evaluate Xtressé Gummy Supplement in Women With Thinning Hair
Androgenetic Alopecia
Not yet recruitingEarly Phase 1
Evaluating the Efficacy of Platelet-rich Plasma Therapy in the Treatment of Androgenic Alopecia
Androgenic Alopecia
Not yet recruitingPhase 3
Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of N1087 in Participants With Female Pattern Hair Loss (MINORA-WOMEN)
Female Pattern Hair Loss, Female Pattern Hair Loss, Androgenic Alopecia

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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing HMI-115-120mg-Q4W, HMI-115-240mg-Q4W and HMI-115, 240mg-Q2W in people with Androgenetic Alopecia, run by Hope Medicine (Nanjing) 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 6 inclusion and 11 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: finished, as of the sponsor's last update on 4 Jun 2025. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Rate of Target Arean Hair Count (TAHC) (time frame: 24 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06118866.

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 4 Jun 2025.