NCT07702890RecruitingPhase 1/2
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
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
Source: ClinicalTrials.gov · Last updated 10 Sept 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 188 (estimated)
- First submitted
- 6 Jul 2026
- Start date
- 27 Jul 2026
- Primary completion date
- Dec 2028
- Lead sponsor
- Gubra A/S
- Diseases
- Obesity, Type 2 diabetes
- NCT number
- NCT07702890
- EU CT number
- 2025-524921-42-00
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 188
- From 27 Jul 2026 to the primary completion date, Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use or planned use of concomitant medication impacting the assessment of trial endpoints
Other illness
- 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
Lab values
- Clinically significant abnormal laboratory parameters
Other
- Women of childbearing potential who are not using highly effective contraception
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| PROFIL Institut fuer Stoffwechselforschung GmbH Coordinator of this site? Confirm its status | Neuss | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.