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

Sponsor
Gubra A/S
Study ID
NCT07702890
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • GUB-UCN2 — DRUG
    GUB-UCN2 will be administered subcutaneously
  • Placebo — DRUG
    Placebo will be administered subcutaneously

Study Details

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

Key Dates

First listed
Jul 14, 2026
Start date
Jul 31, 2026
Status verified
Jul 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
188 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Other: Part 1
    Participants will be randomized to investigational drug or placebo
  • Other: Part 2
    Participants will be randomized to investigational drug or placebo
  • Other: Part 3
    GUB-UCN2 will be investigated as monotherapy and on top of standard of care obesity treatment against placebo

Primary Outcome Measure

Number of Treatment Emergent Adverse Events [ Time Frame: From baseline up to week 22 ]

Central Contacts

Find similar trials

Nationwide
Obesity / overweight trialsType 2 diabetes trialsEndocrinology trialsMetabolic health trialsWeight loss trials

Related Studies