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Study identifier: NCT07702890 Synced from ClinicalTrials.gov · August 09, 2026
● Study status: 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

Condition: Obesity · Type 2 Diabetes  ·  Sponsor: Gubra A/S

PhasePhase 1/Phase 2
Planned participants188
Who can joinAll sexes, 18 Years to 75 Years
Healthy volunteersYesCheck eligibility criteria ↓
WhereNeuss, Germany

Interested? Contact the study team ↓

For sponsors, CROs & site teams
Professional view of this study — listed sites, countries and recruiting context from the public registry. Everything below is written for patients and caregivers.Open the site landscape →

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

This description comes directly from the study's public registry record.

Talk to the study team

Sr. Clinical Trial Manager  ·  +45 3152 2650  ·  drugdevelopment@gubra.dk

There is no obligation to join — the study team can answer your questions about taking part.

Always discuss trial participation with your own doctor first.

Full eligibility criteria (exactly as the study team wrote them)

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

Reproduced word-for-word from the public registry record — the study team can answer questions about it.

Locations (1)

PROFIL Institut fuer Stoffwechselforschung GmbHNeuss, GermanyRecruiting

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Neuss

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