NCT07702890 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
| NCT ID | NCT07702890 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Gubra A/S |
| Condition | Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 188 participants |
| Start Date | 2026-07-27 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 188 participants in total. It began in 2026-07-27 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07702890 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07702890 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07702890 currently recruiting?
Yes, NCT07702890 is actively recruiting participants. Contact the research team at drugdevelopment@gubra.dk for enrollment information.
Where is the NCT07702890 trial being conducted?
This trial is being conducted at Neuss, Germany.
Who is sponsoring the NCT07702890 clinical trial?
NCT07702890 is sponsored by Gubra A/S. The trial plans to enroll 188 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.