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Recruiting NCT07702890

A Three-part First-in-human Trial to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GUB-UCN2 in Healthy Lean and Obese Participants and Participants With T2D

Phase I / Phase II Interventional Obesity Type 2 Diabetes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: GUB-UCN2, Placebo.
Who it may be relevant to
Registry conditions: Obesity, Type 2 Diabetes. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Three-part First-in-human, Single and Multiple Ascending and Repeated Dose Trial to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneous GUB-UCN2 in Healthy Lean and Obese Participants and in Participants With Type 2 Diabetes

Overview

The trial will enroll healthy volunteers and individuals living with obesity, with and without Type 2 Diabetes. The study, with a treatment period of up to 16 weeks in selected cohorts, will investigate GUB-UCN2 as both a standalone therapy and on top of standard of care for obesity

Interventions

  • Drug GUB-UCN2
    GUB-UCN2 will be administered subcutaneously
  • Drug Placebo
    Placebo will be administered subcutaneously

Primary outcome measures

  • Number of Treatment Emergent Adverse Events [Time frame: From baseline up to week 22]
Secondary outcome measures (7)
  • AUC(0-∞),SD [Time frame: From baseline up to week 6]
  • AUC(0-last),SD [Time frame: From baseline up to week 6]
  • tmax,SD [Time frame: From baseline up to week 6]
  • Cmax,SD [Time frame: From baseline up to week 6]
  • AUCτ,SS [Time frame: From baseline up to week 22]
  • Cmax, SS [Time frame: From baseline up to week 22]
  • tmax, SS [Time frame: From baseline up to week 22]

Eligibility criteria

Inclusion criteria

Part 1

  • Signed and dated informed consent obtained before any trial-related activities
  • Males and female participants, aged between 18-55 years
  • Body Mass Index (BMI) between 20.0 and 29.9 kg/m\^2, inclusive
  • Considered generally healthy upon completion of medical history and screening safety assessments

Part 2

  • Signed and dated informed consent obtained before any trial-related activities
  • Male participants, aged between 18-55 years
  • Body Mass Index (BMI) between 30.0 and 35.0 kg/m\^2, inclusive

Part 3 (participants with obesity)

  • Signed and dated informed consent obtained before any trial-related activities
  • Males and female participants, aged between 18-75 years
  • Body Mass Index (BMI) between 30.0 and 45.0 kg/m\^2

Part 3 (participants with T2D)

  • Signed and dated informed consent obtained before any trial-related activities
  • Male and female participants, aged between 18-75 years
  • Body Mass Index (BMI) between 27.0 and 35.0 kg/m\^2
  • Diagnosed with type 2 diabetes mellitus, HbA1c ≤ 69.0 mmol/mol (≤ 8.5%)
  • Stable daily dose of antidiabetic medication

Exclusion criteria

  • Known history of serious adverse reactions or serious hypersensitivity to drug or formulation excipients
  • Presence or history of clinically significant gastrointestinal, cardiovascular, renal, hepatic, dermatological, respiratory, neurological, psychiatric, malignant, metabolic, endocrinological, hematologic or venereal disorder
  • Use or planned use of concomitant medication impacting the assessment of trial endpoints
  • Clinically significant abnormal laboratory parameters
  • Women of childbearing potential who are not using highly effective contraception

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Sequential
Masking
Double blind
Primary purpose
Treatment

Study locations

Germany · 1 center
  • PROFIL Institut fuer Stoffwechselforschung GmbH — Neuss

Identifiers

NCT: NCT07702890 · GUB-UCN2 · 2025-524921-42-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗