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 · NCT07702890 · Interventional (participants receive a specific treatment) · Lead sponsor: Gubra A/S
View the official record on ClinicalTrials.gov →Interventions studied
GUB-UCN2Placebo
What this trial is about
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
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Phase 1, Phase 2
Study type
Interventional (participants receive a specific treatment)
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 is running
1 location listed.
- PROFIL Institut fuer Stoffwechselforschung GmbH - Neuss, Germany