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

Sponsor
Hudson Biotech
Study ID
NCT07505745
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Insulin Resistance
  • Overweight/Obesity
  • Prediabetes

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • MOTS-c (MDP) — DRUG
    Drug: MOTS-c (MDP)
  • Placebo — DRUG
    Drug: Placebo
  • Route Subcutaneous injection — OTHER
    injection
  • Regimen — OTHER
    Fixed dose once daily for 12 weeks

Study Details

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.

Key Dates

First listed
Apr 1, 2026
Start date
Feb 2, 2026
Status verified
Mar 2026
Primary completion
Feb 14, 2027
Completion
May 17, 2028

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: MOTS-c
    Participants receive investigational MOTS-c plus standardized lifestyle counseling.
  • Placebo Comparator: Placebo
    Participants receive matching placebo plus standardized lifestyle counseling.

Primary Outcome Measure

Change from baseline in OGTT-derived insulin sensitivity (Matsuda Index) [ Time Frame: 12 Weeks ]

Central Contacts

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