First Safety Study of GUB-UCN2 in Obesity and Type 2 Diabetes
Tests GUB-UCN2 injections in healthy adults and people with obesity or type 2 diabetes.
Plain-language title generated from the registry record
Registry title: 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
Key facts
- Where
- Neuss, GermanySee the site
- Phase
- Phase 1/2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07702890, who can take part
Where in Germany
- PROFIL Institut fuer Stoffwechselforschung GmbHNeuss, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Gubra A/S
- Trial code
- NCT07702890EU 2025-524921-42-00
- Record updated
- 10 September 2026
- Original description
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 obesityRead full original descriptionShow less
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
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
Inclusion: 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: Use or planned use of concomitant medication impacting the assessment of trial endpoints; 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; Clinically significant abnormal laboratory parameters; Women of childbearing potential who are not using highly effective contraception.