Skip to content

Trial · Interventional

RecruitingPhase 2Registry data

MOTS-c for Improving Insulin Sensitivity in Adults With Prediabetes and Overweight/Obesity

Short name MOTS-MET

Overview

Status
Recruiting
Phase
Phase 2
Enrollment
120 participants (estimated)
Sponsor
Hudson Biotech · Industry
Design
Randomized · Quadruple masking
Countries
1 country

China

Start
2 Feb 2026
Primary completion
14 Feb 2027 (estimated)
Completion
17 May 2028 (estimated)
First posted
1 Apr 2026
Last update posted
1 Apr 2026
Conditions
Prediabetes · Insulin Resistance · Overweight/Obesity

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2026202720282029
  1. Ph 2

    MOTS-MET

    NCT07505745

    2 Feb 2026 to est. 17 May 2028

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • MOTS-c (MDP)Drug
  • PlaceboDrug
  • Route Subcutaneous injectionOther
  • RegimenOther

Arms2

  • Experimental

    MOTS-c

    Participants receive investigational MOTS-c plus standardized lifestyle counseling.

  • Placebo comparator

    Placebo

    Participants receive matching placebo plus standardized lifestyle counseling.

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Change from baseline in OGTT-derived insulin sensitivity (Matsuda Index)

    Time frame · 12 Weeks

  2. Incidence of treatment-emergent adverse events (TEAEs)

    Time frame · 16 weeks

Secondary outcomes(4)
  1. Change from baseline in HbA1c.

    Time frame · 12 Weeks

  2. Change from baseline in fasting glucose

    Time frame · 12 weeks

  3. Change from baseline in 2-hour plasma glucose during 75 g OGTT.

    Time frame · 12 weeks

  4. Immunogenicity (anti-drug antibodies, if applicable).

    Time frame · 16 weeks

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 65 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 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. Exclusion Criteria: * 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). * 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).

PepBank is a research reference. Talk to a doctor before you use any peptide.