Trial intelligence / Profile preview

GUB-UCN2 in Healthy Volunteers, Obesity, and Type 2 Diabetes

NCT07702890Phase 2

Key facts

Status
Recruiting
Start
Jul 2026
Primary completion
Dec 2028
Countries
1
Sponsor
Gubra
Conditions
obesitytype 2 diabetes mellitus (T2DM)
01

Overview

Phase 2, randomised trial of GUB-UCN2 in obesity and type 2 diabetes mellitus (T2DM) (3 arms), sponsored by Gubra. Primary endpoint: Number of Treatment Emergent Adverse Events. Started Jul 2026; status: recruiting.

02

Design

3 arms
Study design
Randomized
  • Part 1

    Healthy volunteers randomized to GUB-UCN2 or placebo.

  • Part 2

    Males with obesity randomized to GUB-UCN2 or placebo.

  • Part 3

    Participants with obesity or T2D randomized to GUB-UCN2 (monotherapy or + SOC) or placebo.

03

Who it enrols

Healthy volunteers (BMI 20-29.9), males with obesity (BMI 30-35), and males/females with obesity (BMI 30-45) or Type 2 Diabetes (BMI 27-35, HbA1c <= 8.5% on stable antidiabetic medication).

04

Endpoints

Primary

  • Number of Treatment Emergent Adverse Events

Secondary

  • Area Under the Curve from zero to infinity

  • Area Under the Curve from zero to last measurable concentration

  • Time to maximum concentration

  • Maximum concentration

  • Area Under the Curve over the dosing interval at steady state

  • Maximum concentration at steady state

  • Time to maximum concentration at steady state

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