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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

NCT07702890

RecruitingPhase 1, Phase 2

Sponsor: Gubra A/S

Conditions: Obesity, Type 2 Diabetes

Interventions: GUB-UCN2, Placebo

Countries: Germany

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 overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

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

Locations (1)

Neuss, Germany