Recruiting
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
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
ClinicalTrials.gov IDNCT07702890
PhasePHASE1, PHASE2
Enrollment188
SponsorGubra A/S
Age18 Years – 75 Years
SexALL
Conditions studied
Obesity, Type 2 Diabetes
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
Interventions
- Drug: GUB-UCN2 — GUB-UCN2 will be administered subcutaneously
- Drug: Placebo — Placebo will be administered subcutaneously
Primary outcomes
- Number of Treatment Emergent Adverse Events (From baseline up to week 22)
Eligibility information
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
Study locations
- PROFIL Institut fuer Stoffwechselforschung GmbH, Neuss, Germany
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-11-01.