Trials / Active Not Recruiting

Active Not RecruitingNCT07055516

Evaluate the Efficacy and Safety of NT-0796 in Participants With Obesity With or Without Type 2 Diabetes Mellitus

A Phase 2a Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of NT-0796 as an Adjunct to a Reduced Calorie Diet and Increased Physical Activity in Obese Participants With/Without Type 2 Diabetes

Status: Active Not Recruiting
Phase: Phase 2
Study type: Interventional
Enrollment: 176 (actual)

Sponsor: NodThera Limited · Industry
Sex: All
Age: 18 Years – 75 Years
Healthy volunteers: Not accepted

Summary

Detailed description

Potential participants will be screened within 28 days prior to baseline (Day 1), and eligible participants will be randomized 1:1:1 within each strata (T2DM or non-T2DM) to either NT-0796 twice daily (BID), NT-0796 once daily (QD) or placebo (BID). Study drug will be administered orally. Following 24 weeks of active treatment, participants will enter a 4-week safety follow-up before being discharged from the study. The primary endpoint of the study will be percentage weight change from baseline, the key-secondary endpoint will be change in HbA1c from baseline in the T2DM stratum, while secondary endpoints include DEXA scans, a variety of other relevant biometric measures as well as biomarkers. Pharmacokinetic, safety and tolerability as well as suicidality will also be assessed.

Conditions

Obesity and Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	NT-0796	Orally administered capsules
DRUG	Placebo	Orally administered capsules

Timeline

Start date: 2025-05-08
Primary completion: 2026-05-21
Completion: 2026-05-21
First posted: 2025-07-09
Last updated: 2026-04-08

Locations

11 sites across 1 country: United States

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT07055516. Inclusion in this directory is not an endorsement.