Health TrialsbyHealthPanel

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

ConditionsPrediabetesInsulin ResistanceOverweight/Obesity
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorHudson Biotech

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 to 65 years at the time of consent.

Body mass index (BMI) 27.0 to 40.0 kg/m².

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • MOTS-c (MDP)

    Drug

    Drug: MOTS-c (MDP)

  • Placebo

    Drug

    Drug: Placebo

  • Route Subcutaneous injection

    Other intervention

    injection

  • Regimen

    Other intervention

    Fixed dose once daily for 12 weeks

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: MOTS-cExperimental treatment 3 interventions
Group B: PlaceboPlacebo comparator 3 interventions

Trial outcomes

Primary outcomes

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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hudson Biotech

Lead sponsor

Source ClinicalTrials.gov
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