NCT07702890

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
188

participants targeted

Target at P75+ for phase_1 obesity

Timeline
28mo left

Started Jul 2026

Longer than P75 for phase_1 obesity

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress3%
Jul 2026Dec 2028

Study Start

First participant enrolled

July 1, 2026

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

July 6, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 14, 2026

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

July 29, 2026

Status Verified

July 1, 2026

Enrollment Period

2.4 years

First QC Date

July 6, 2026

Last Update Submit

July 28, 2026

Conditions

ObesityType 2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Number of Treatment Emergent Adverse Events

    From baseline up to week 22

Secondary Outcomes (7)

  • AUC(0-∞),SD

    From baseline up to week 6

  • AUC(0-last),SD

    From baseline up to week 6

  • tmax,SD

    From baseline up to week 6

  • Cmax,SD

    From baseline up to week 6

  • AUCτ,SS

    From baseline up to week 22

  • +2 more secondary outcomes

Study Arms (3)

Part 1

OTHER

Participants will be randomized to investigational drug or placebo

Drug: GUB-UCN2Drug: Placebo

Part 2

OTHER

Participants will be randomized to investigational drug or placebo

Drug: GUB-UCN2Drug: Placebo

Part 3

OTHER

GUB-UCN2 will be investigated as monotherapy and on top of standard of care obesity treatment against placebo

Drug: GUB-UCN2Drug: Placebo

Interventions

GUB-UCN2DRUG

GUB-UCN2 will be administered subcutaneously

Part 1Part 2Part 3
PlaceboDRUG

Placebo will be administered subcutaneously

Part 1Part 2Part 3

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +4 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PROFIL Institut fuer Stoffwechselforschung GmbH

Neuss, Germany

RECRUITING

MeSH Terms

Conditions

ObesityDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Central Study Contacts

Sr. Clinical Trial Manager

CONTACT

+45 3152 2650drugdevelopment@gubra.dk

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: Parts 1 and 2: Single Group assignment. Part 3: Parallel assignment
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2026

First Posted

July 14, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

July 29, 2026

Record last verified: 2026-07

Locations

DE(1)