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Recruiting Phase 1 / Phase 2

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

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About this study

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

Condition
Obesity, Type 2 Diabetes
Tested
GUB-UCN2, Placebo
Sponsor
Gubra A/S

Who can join

Age
18 to 75 years
Sex
All sexes
Healthy volunteers
Accepted

Inclusion 19

  • Minimum age: 18 years
  • Maximum age: 75 years
  • Study condition: Obesity, Type 2 Diabetes
  • 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
  • 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)
  • 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)
  • 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 5

  • 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

1 site, 1 recruiting

PROFIL Institut fuer Stoffwechselforschung GmbH

Neuss, Germany

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.