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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

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

Recruiting
18-75 years
All
Phase 1/2

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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

Eligibility

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

Study details
    Obesity
    Type 2 Diabetes

NCT07702890

Gubra A/S

1 August 2026

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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