Clinical trial
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 now · Phase 1, Phase 2 · 1 countries · Registry ID NCT07702890
Recruiting nowPhase 1, Phase 2Interventional
What this study 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
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age18 Years to 75 Years
SexAll
Healthy volunteersAccepted
ConditionObesity, Type 2 Diabetes
Full registry 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
Treatments and study arms
GUB-UCN2
Drug
GUB-UCN2 will be administered subcutaneously
Placebo
Drug
Placebo will be administered subcutaneously
Primary outcomes
Number of Treatment Emergent Adverse EventsFrom baseline up to week 22
Study locations
1 locations were listed when this page was built. The first 40 are shown.
PROFIL Institut fuer Stoffwechselforschung GmbH🇩🇪 Neuss, Germany