Valid MeSH ConditiongsPhase 1NCT07840729
Evaluate the Safety and Tolerability of Multiple Doses of JMT206 Injection in Obese Participants
A Phase 1 study testing JMT206 injection and Semaglutide injection in people with Valid MeSH Conditiongs, run by Shanghai JMT-Bio Inc. at 1 site in China.
Trial summary
Use these resources to provide understandable information about this study to patients, families, and health care providers: Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Valid MeSH Conditiongs
- What is being tested?
- JMT206 injection and Semaglutide injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 20 Oct 2026to 30 Apr 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
- Age 18~65 (including threshold values), male or female participants;
- BMI ≥ 30 kg/m²;
- Weight change <5% within the 3 months prior to screening
- Voluntarily sign the informed consent form before the trial..
Who cannot join
- 1) Those known to have a history of allergy to any component or related preparations in the investigational drug and its excipients, or have severe allergic diseases or allergic constitution; 2) Participants with a history of diabetes mellitus or hypoglycemic episodes; 3) Obesity is related to medication or diseases; Or weight gain caused by non-fat content; or monogene mutationsobesity; 4) History of weight loss surgery and/or treatment within the past year; 5) History of severe gastrointestinal disease or gastrointestinal surgery, clinically significant gastric emptying abnormalities, or long-term use of medications directly affecting gastrointestinal motility; 6) Having comorbidities known to affect skeletal muscle proteins; 7) A history of acute or chronic pancreatitis; 8) Acute gallbladder disease within one year prior to screening; 9) Previous or family history of medullary thyroid carcinoma or type 2 endocrine adenomatosis; 10) Severe cardiovascular or cerebrovascular events within 6 months prior to screening; 11) Any type of treated or untreated malignant tumor within 5 years prior to screening; 12) History of severe mental illness; 13) Use of drugs or products that may cause weight changes within 3 months prior to screening; 14) Use of drugs or products affecting skeletal muscle synthesis within 3 months prior to screening; 15) Participants deemed otherwise unsuitable for this trial by the investigator.
- -
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 University People's Hospital
Beijing
Linong Ji, +86 13910978815, jiln@bjmu.edu.cn
About this study
Official title: Identify the Expanded Access Program, if Any. This is Required Unless the Expanded Access Type is "Individual Patients." A Randomized, Parallel, Double-blind, Placebo-controlled Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of JMT206 Injection Alone or in Combination With Semaglutide in Obese Participants
Use these resources to provide understandable information about this study to patients, families, and health care providers:
- Conditions
- Valid MeSH Conditiongs
- Being tested
- JMT206 injection, Semaglutide injection, Placebo injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JMT206 injectionDrug
JMT206 injection administered subcutaneously (SC) once a week
Semaglutide injectionCombination product
Semaglutide administered subcutaneously once a week, starts from lower dose and is gradually increased.
Placebo injectionDrug
Placebo administered subcutaneously (SC) once a week.
| Study group | Role | What they receive |
|---|---|---|
| JMT206 injection group 2 | Experimental | JMT206 injection dose 2 administered subcutaneously (SC) once a week Receives: Drug: JMT206 injection |
| JMT206 injection group 3 | Experimental | JMT206 injection dose 3 administered subcutaneously (SC) once a week Receives: Drug: JMT206 injection |
| JMT206 injection + Semaglutide group 1 | Experimental | JMT206 injection dose 1 administered subcutaneously (SC) once a week. Semaglutide administered subcutaneously once a week, starts from lower dose and is gradually increased. Receives: Drug: JMT206 injection; Combination Product: Semaglutide injection |
| JMT206 injection + Semaglutide group 2 | Experimental | JMT206 injection dose 2 administered subcutaneously (SC) once a week. Semaglutide administered subcutaneously once a week, starts from lower dose and is gradually increased. Receives: Drug: JMT206 injection; Combination Product: Semaglutide injection |
| JMT206 injection + Semaglutide group 3 | Experimental | JMT206 injection dose 3 administered subcutaneously (SC) once a week. Semaglutide administered subcutaneously once a week, starts from lower dose and is gradually increased Receives: Drug: JMT206 injection; Combination Product: Semaglutide injection |
| Placebo | Placebo comparator | Placebo administered subcutaneously (SC) once a week Receives: Drug: Placebo injection |
| Placebo+ Semaglutide | Placebo comparator | Placebo administered subcutaneously (SC) once a week. Semaglutide administered subcutaneously once a week, starts from lower dose and is gradually increased. Receives: Combination Product: Semaglutide injection; Drug: Placebo injection |
| JMT206 injection group 1 | Experimental | JMT206 injection dose 1 administered subcutaneously (SC) once a week Receives: Drug: JMT206 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events (AE) assessed by CTCAE v6.0
Measured: Baseline through week 19
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start20 Oct 2026
- Primary completion28 Feb 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Valid MeSH ConditiongsStudies of the same condition, open and under way.
- More trials run by Shanghai JMT-Bio Inc.The sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai JMT-Bio Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07840729
- Sponsor's protocol ID
- JMT206-003
- Status last verified
- Oct 2026
- First submitted
- 20 Sep 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identify the Expanded Access Program, if Any. This is Required Unless the Expanded Access Type is "Individual Patients." A Randomized, Parallel, Double-blind, Placebo-controlled Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of JMT206 Injection Alone or in Combination With Semaglutide in Obese Participants
- ClinicalTrials.gov ID
- NCT07840729
- Acronym / sponsor ID
- JMT206-003
- Conditions
- Valid MeSH Conditiongs
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Shanghai JMT-Bio Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Oct 2026 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 25 Sep 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.
Use these resources to provide understandable information about this study to patients, families, and health care providers:
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| JMT206 injection group 2 | Experimental | Drug: JMT206 injectionJMT206 injection dose 2 administered subcutaneously (SC) once a week |
| JMT206 injection group 3 | Experimental | Drug: JMT206 injectionJMT206 injection dose 3 administered subcutaneously (SC) once a week |
| JMT206 injection + Semaglutide group 1 | Experimental | Drug: JMT206 injection, Combination Product: Semaglutide injectionJMT206 injection dose 1 administered subcutaneously (SC) once a week. Semaglutide administered subcutaneously once a week, starts from lower dose and is gradually increased. |
| JMT206 injection + Semaglutide group 2 | Experimental | Drug: JMT206 injection, Combination Product: Semaglutide injectionJMT206 injection dose 2 administered subcutaneously (SC) once a week. Semaglutide administered subcutaneously once a week, starts from lower dose and is gradually increased. |
| JMT206 injection + Semaglutide group 3 | Experimental | Drug: JMT206 injection, Combination Product: Semaglutide injectionJMT206 injection dose 3 administered subcutaneously (SC) once a week. Semaglutide administered subcutaneously once a week, starts from lower dose and is gradually increased |
| Placebo | Placebo comparator | Drug: Placebo injectionPlacebo administered subcutaneously (SC) once a week |
| Placebo+ Semaglutide | Placebo comparator | Combination Product: Semaglutide injection, Drug: Placebo injectionPlacebo administered subcutaneously (SC) once a week. Semaglutide administered subcutaneously once a week, starts from lower dose and is gradually increased. |
| JMT206 injection group 1 | Experimental | Drug: JMT206 injectionJMT206 injection dose 1 administered subcutaneously (SC) once a week |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18~65 (including threshold values), male or female participants;
- BMI ≥ 30 kg/m²;
- Weight change <5% within the 3 months prior to screening
- Voluntarily sign the informed consent form before the trial..
Key exclusion criteria (2 listed)
- 1) Those known to have a history of allergy to any component or related preparations in the investigational drug and its excipients, or have severe allergic diseases or allergic constitution; 2) Participants with a history of diabetes mellitus or hypoglycemic episodes; 3) Obesity is related to medication or diseases; Or weight gain caused by non-fat content; or monogene mutationsobesity; 4) History of weight loss surgery and/or treatment within the past year; 5) History of severe gastrointestinal disease or gastrointestinal surgery, clinically significant gastric emptying abnormalities, or long-term use of medications directly affecting gastrointestinal motility; 6) Having comorbidities known to affect skeletal muscle proteins; 7) A history of acute or chronic pancreatitis; 8) Acute gallbladder disease within one year prior to screening; 9) Previous or family history of medullary thyroid carcinoma or type 2 endocrine adenomatosis; 10) Severe cardiovascular or cerebrovascular events within 6 months prior to screening; 11) Any type of treated or untreated malignant tumor within 5 years prior to screening; 12) History of severe mental illness; 13) Use of drugs or products that may cause weight changes within 3 months prior to screening; 14) Use of drugs or products affecting skeletal muscle synthesis within 3 months prior to screening; 15) Participants deemed otherwise unsuitable for this trial by the investigator.
- -
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 |
|---|---|---|
| JMT206 injectionJMT206 injection administered subcutaneously (SC) once a week | Drug | JMT206 injection + Semaglutide group 1, JMT206 injection + Semaglutide group 2, JMT206 injection + Semaglutide group 3, JMT206 injection group 1, JMT206 injection group 2, JMT206 injection group 3 |
| Semaglutide injectionSemaglutide administered subcutaneously once a week, starts from lower dose and is gradually increased. | Combination product | JMT206 injection + Semaglutide group 1, JMT206 injection + Semaglutide group 2, JMT206 injection + Semaglutide group 3, Placebo+ Semaglutide |
| Placebo injectionPlacebo administered subcutaneously (SC) once a week. | Drug | Placebo, Placebo+ Semaglutide |
Primary outcome
Incidence of Adverse Events (AE) assessed by CTCAE v6.0
Time frame: Baseline through week 19
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 2 Nov 2026.
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 JMT206 injection and Semaglutide injection in people with Valid MeSH Conditiongs, run by Shanghai JMT-Bio Inc. 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 4 inclusion and 2 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 2 Nov 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 Clinical Trials Information Group officer (86-0311-69085587, ctr-contact@mail.ecspc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events (AE) assessed by CTCAE v6.0 (time frame: Baseline through week 19). 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 2 Nov 2026.