PrediabetesPhase 2MOTS-METNCT07505745
MOTS-c for Improving Insulin Sensitivity in Adults With Prediabetes and Overweight/Obesity
A Phase 2 study testing MOTS-c (MDP), Route Subcutaneous injection and Regimen in people with Prediabetes and Insulin Resistance, run by Hudson Biotech at 1 site in China.
Trial summary
This Phase 2a study evaluates whether 12 weeks of treatment with investigational MOTS-c improves insulin sensitivity compared with placebo in adults with prediabetes and overweight/obesity. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Prediabetes, Insulin Resistance, Overweight/Obesity
- What is being tested?
- MOTS-c (MDP), Route Subcutaneous injection and Regimen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 2 Feb 2026to 17 May 2028
- Phase
- Phase 2
- 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 to 65 years at the time of consent.
- Body mass index (BMI) 27.0 to 40.0 kg/m^2.
- Prediabetes documented at screening by any of the following: (a) HbA1c 5.7% to 6.4%; (b) fasting plasma glucose 100 to 125 mg/dL; or (c) 2-hour plasma glucose 140 to 199 mg/dL during a 75 g OGTT.
- Stable body weight (less than 5% change) for at least 3 months prior to screening.
- Willingness to maintain stable diet and physical activity patterns during the 12-week treatment period.
- For participants of childbearing potential: agreement to use highly effective contraception for the study duration and for a protocol-specified period after last dose.
- Ability to understand and sign informed consent.
Who cannot join
- Diabetes mellitus (e.g., HbA1c 6.5% or higher, fasting plasma glucose 126 mg/dL or higher, or 2-hour glucose 200 mg/dL or higher at screening).
- Use of glucose-lowering medications (including metformin, GLP-1 receptor agonists, SGLT2 inhibitors) within 3 months prior to screening.
- History of bariatric surgery or planned weight-loss surgery during the study period.
- Clinically significant cardiovascular disease within 6 months (e.g., myocardial infarction, stroke, unstable angina) or uncontrolled hypertension.
- Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m^2, clinically significant hepatic disease, or ALT/AST > 2.5x upper limit of normal at screening.
- Active malignancy requiring treatment (except adequately treated non-melanoma skin cancer).
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- Pregnant, breastfeeding, or planning pregnancy during the study period.
- Known hypersensitivity to peptide therapeutics or any component of the investigational product formulation.
- Any condition that, in the investigator's judgment, would interfere with study participation or interpretation of results (e.g., inability to comply with study procedures).
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 Shenzhen Hospital
Shenzhen, Guangdong, 518036
Zhen J Peng, Phd, +86 13076790039, Zhen-Peng@beijing-biotech.com
About this study
Official title: A Phase 2a, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Pharmacodynamics of MOTS-c (a Mitochondrial-Derived Peptide) in Adults With Prediabetes and Overweight/Obesity
This Phase 2a study evaluates whether 12 weeks of treatment with investigational MOTS-c improves insulin sensitivity compared with placebo in adults with prediabetes and overweight/obesity.
Participants are randomized 1:1 to MOTS-c or placebo, receive standardized lifestyle counseling, and are followed for safety through Week 16.
Read the detailed description
Mitochondrial-derived peptides (MDPs) are small peptides encoded by mitochondrial DNA that can act as signaling molecules. MOTS-c (mitochondrial open reading frame of the 12S rRNA type-c) has been reported to regulate insulin sensitivity and metabolic homeostasis in preclinical studies, with skeletal muscle identified as a key target tissue and AMPK activation proposed as a downstream mechanism. Based on these findings, this trial is designed to test the hypothesis that MOTS-c can improve insulin sensitivity and cardiometabolic risk markers in humans with early metabolic dysfunction. The study includes a screening period (up to 4 weeks), a 12-week double-blind treatment period, and a 4-week post-treatment safety follow-up. Efficacy is assessed using a 75 g oral glucose tolerance test (OGTT)-derived insulin sensitivity index and standard metabolic endpoints (HbA1c, fasting glucose, lipids, body weight, and waist circumference). Safety assessments include adverse events, vital signs, ECG, and laboratory testing.
- Conditions
- Prediabetes, Insulin Resistance, Overweight/Obesity
- Being tested
- MOTS-c (MDP), Placebo, Route Subcutaneous injection, Regimen
- Keywords
- MOTS-c, mitochondrial-derived peptide, MDP, insulin sensitivity, AMPK, prediabetes, metabolic syndrome, OGTT, HbA1c
- Medical subject headings
- Prediabetic State, Insulin Resistance, Overweight, Obesity, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MOTS-c (MDP)Drug
Drug: MOTS-c (MDP)
PlaceboDrug
Drug: Placebo
Route Subcutaneous injectionOther
injection
RegimenOther
Fixed dose once daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| MOTS-c | Experimental | Participants receive investigational MOTS-c plus standardized lifestyle counseling. Receives: Drug: MOTS-c (MDP); Other: Route Subcutaneous injection; Other: Regimen |
| Placebo | Placebo comparator | Participants receive matching placebo plus standardized lifestyle counseling. Receives: Drug: Placebo; Other: Route Subcutaneous injection; Other: Regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in OGTT-derived insulin sensitivity (Matsuda Index)
Measured: 12 Weeks
Incidence of treatment-emergent adverse events (TEAEs)
Measured: 16 weeks
Secondary outcomes (4)
Change from baseline in HbA1c.
Measured: 12 Weeks
Change from baseline in fasting glucose
Measured: 12 weeks
Change from baseline in 2-hour plasma glucose during 75 g OGTT.
Measured: 12 weeks
Immunogenicity (anti-drug antibodies, if applicable).
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2026
- Study start2 Feb 2026
- Primary completion14 Feb 2027 (estimated)
- Study completion17 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrediabetesStudies 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
- Model description
- Two-arm, multicenter, randomized, double-blind, placebo-controlled, parallel-group design (1:1 allocation).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hudson Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07505745
- Sponsor's protocol ID
- EX-MOTS-2A-001
- Acronym
- MOTS-MET
- Status last verified
- Mar 2026
- First submitted
- 14 Mar 2026
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Pharmacodynamics of MOTS-c (a Mitochondrial-Derived Peptide) in Adults With Prediabetes and Overweight/Obesity
- ClinicalTrials.gov ID
- NCT07505745
- Acronym / sponsor ID
- MOTS-MET / EX-MOTS-2A-001
- Conditions
- Prediabetes, Insulin Resistance, Overweight/Obesity
- Keywords
- MOTS-c, mitochondrial-derived peptide, MDP, insulin sensitivity, AMPK, prediabetes, metabolic syndrome, OGTT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Hudson BiotechIndustry (pharma, biotech, devices)
- Study start
- 2 Feb 2026 (actual)
- Primary completion
- 14 Feb 2027 (estimated)
- Study completion
- 17 May 2028 (estimated)
- First posted
- 1 Apr 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 Phase 2a study evaluates whether 12 weeks of treatment with investigational MOTS-c improves insulin sensitivity compared with placebo in adults with prediabetes and overweight/obesity.
Participants are randomized 1:1 to MOTS-c or placebo, receive standardized lifestyle counseling, and are followed for safety through Week 16.
Detailed description
Mitochondrial-derived peptides (MDPs) are small peptides encoded by mitochondrial DNA that can act as signaling molecules. MOTS-c (mitochondrial open reading frame of the 12S rRNA type-c) has been reported to regulate insulin sensitivity and metabolic homeostasis in preclinical studies, with skeletal muscle identified as a key target tissue and AMPK activation proposed as a downstream mechanism. Based on these findings, this trial is designed to test the hypothesis that MOTS-c can improve insulin sensitivity and cardiometabolic risk markers in humans with early metabolic dysfunction. The study includes a screening period (up to 4 weeks), a 12-week double-blind treatment period, and a 4-week post-treatment safety follow-up. Efficacy is assessed using a 75 g oral glucose tolerance test (OGTT)-derived insulin sensitivity index and standard metabolic endpoints (HbA1c, fasting glucose, lipids, body weight, and waist circumference). Safety assessments include adverse events, vital signs, ECG, and laboratory testing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two-arm, multicenter, randomized, double-blind, placebo-controlled, parallel-group design (1:1 allocation).
| Arm | Type | Receives |
|---|---|---|
| MOTS-c | Experimental | Drug: MOTS-c (MDP), Other: Route Subcutaneous injection, Other: RegimenParticipants receive investigational MOTS-c plus standardized lifestyle counseling. |
| Placebo | Placebo comparator | Drug: Placebo, Other: Route Subcutaneous injection, Other: RegimenParticipants receive matching placebo plus standardized lifestyle counseling. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 to 65 years at the time of consent.
- Body mass index (BMI) 27.0 to 40.0 kg/m^2.
- Prediabetes documented at screening by any of the following: (a) HbA1c 5.7% to 6.4%; (b) fasting plasma glucose 100 to 125 mg/dL; or (c) 2-hour plasma glucose 140 to 199 mg/dL during a 75 g OGTT.
- Stable body weight (less than 5% change) for at least 3 months prior to screening.
- Willingness to maintain stable diet and physical activity patterns during the 12-week treatment period.
Key exclusion criteria (9 listed)
- Diabetes mellitus (e.g., HbA1c 6.5% or higher, fasting plasma glucose 126 mg/dL or higher, or 2-hour glucose 200 mg/dL or higher at screening).
- Use of glucose-lowering medications (including metformin, GLP-1 receptor agonists, SGLT2 inhibitors) within 3 months prior to screening.
- History of bariatric surgery or planned weight-loss surgery during the study period.
- Clinically significant cardiovascular disease within 6 months (e.g., myocardial infarction, stroke, unstable angina) or uncontrolled hypertension.
- Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m^2, clinically significant hepatic disease, or ALT/AST > 2.5x upper limit of normal at screening.
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 |
|---|---|---|
| MOTS-c (MDP)Drug: MOTS-c (MDP) | Drug | MOTS-c |
| PlaceboDrug: Placebo | Drug | Placebo |
| Route Subcutaneous injectioninjection | Other | MOTS-c, Placebo |
| RegimenFixed dose once daily for 12 weeks | Other | MOTS-c, Placebo |
Primary outcome
Change from baseline in OGTT-derived insulin sensitivity (Matsuda Index)
Time frame: 12 Weeks
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: 16 weeks
4 secondary outcomes
Change from baseline in HbA1c.
Time frame: 12 Weeks
Change from baseline in fasting glucose
Time frame: 12 weeks
Change from baseline in 2-hour plasma glucose during 75 g OGTT.
Time frame: 12 weeks
Immunogenicity (anti-drug antibodies, if applicable).
Time frame: 16 weeks
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 1 Apr 2026.
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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 2 study testing MOTS-c (MDP), Route Subcutaneous injection and Regimen in people with Prediabetes and Insulin Resistance, run by Hudson Biotech 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 7 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 1 Apr 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 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?
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 Seni S Lu, Phd (+86 13076790030, Seni-Lu@beijing-biotech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in OGTT-derived insulin sensitivity (Matsuda Index) (time frame: 12 Weeks). The study lists 2 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 1 Apr 2026.