GUB-UCN2 in healthy, obese, and T2D adults: a first-in-human safety and pharmacology study

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This first-in-human trial includes three parts to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics of GUB-UCN2. Participants include healthy volunteers, adults with obesity, and adults with obesity and type 2 diabetes. The study uses placebo-controlled cohorts over up to 16 weeks, with GUB-UCN2 given alone or on top of standard obesity care. It aims to determine appropriate dosing ranges and gather initial efficacy signals across diverse BMI and diabetes statuses.

Why it matters

Who can join: the full rules

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

Where it's running

• PROFIL Institut fuer Stoffwechselforschung GmbH
  Neuss, Germany Recruiting

Study contacts

• Study coordinator: Sr. Clinical Trial Manager
• Email: drugdevelopment@gubra.dk
• Phone: +45 3152 2650

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.