ObesityPhase 1/2NCT07702890
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
A Phase 1/2 study testing GUB-UCN2 in people with Obesity and Type 2 Diabetes, run by Gubra A/S at 1 site in Germany.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Type 2 Diabetes
- What is being tested?
- GUB-UCN2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 188 participants
- Where
- 1 siteGermany
- Study dates
- 27 Jul 2026to Dec 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 19Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
PROFIL Institut fuer Stoffwechselforschung GmbH
Neuss
About this study
Official title: A Three-part First-in-human, Single and Multiple Ascending and Repeated Dose Trial to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneous GUB-UCN2 in Healthy Lean and Obese Participants and in Participants With Type 2 Diabetes
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
- Conditions
- Obesity, Type 2 Diabetes
- Being tested
- GUB-UCN2, Placebo
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GUB-UCN2Drug
GUB-UCN2 will be administered subcutaneously
PlaceboDrug
Placebo will be administered subcutaneously
| Study group | Role | What they receive |
|---|---|---|
| Part 1 | Other | Participants will be randomized to investigational drug or placebo Receives: Drug: GUB-UCN2; Drug: Placebo |
| Part 2 | Other | Participants will be randomized to investigational drug or placebo Receives: Drug: GUB-UCN2; Drug: Placebo |
| Part 3 | Other | GUB-UCN2 will be investigated as monotherapy and on top of standard of care obesity treatment against placebo Receives: Drug: GUB-UCN2; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Treatment Emergent Adverse Events
Measured: From baseline up to week 22
Secondary outcomes (7)
AUC(0-∞),SD
Area under the GUB-UCN2 time-concentration curve from zero to infinity
Measured: From baseline up to week 6
AUC(0-last),SD
Area under the GUB-UCN2 time-concentration curve from zero to last quantifiable observation
Measured: From baseline up to week 6
tmax,SD
Time to maximum observed GUB-UCN2 concentration up to the last sample collection
Measured: From baseline up to week 6
Cmax,SD
Maximum observed GUB-UCN2 concentration after single dose
Measured: From baseline up to week 6
AUCτ,SS
Area under the GUB-UCN2 concentration time-curve
Measured: From baseline up to week 22
Cmax, SS
Maximum observed GUB-UCN2 concentration
Measured: From baseline up to week 22
tmax, SS
Time to maximum observed GUB-UCN2 concentration
Measured: From baseline up to week 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start27 Jul 2026
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Parts 1 and 2: Single Group assignment. Part 3: Parallel assignment
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 188 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gubra A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07702890
- Sponsor's protocol ID
- GUB-UCN2
- Other IDs
- 2025-524921-42-00, 2025
- Status last verified
- Jul 2026
- First submitted
- 6 Jul 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Three-part First-in-human, Single and Multiple Ascending and Repeated Dose Trial to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneous GUB-UCN2 in Healthy Lean and Obese Participants and in Participants With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT07702890
- Acronym / sponsor ID
- GUB-UCN2
- Conditions
- Obesity, Type 2 Diabetes
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 188 participants (estimated)
- Lead sponsor
- Gubra A/SIndustry (pharma, biotech, devices)
- Study start
- 27 Jul 2026 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 14 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Parts 1 and 2: Single Group assignment. Part 3: Parallel assignment
| Arm | Type | Receives |
|---|---|---|
| Part 1 | Other | Drug: GUB-UCN2, Drug: PlaceboParticipants will be randomized to investigational drug or placebo |
| Part 2 | Other | Drug: GUB-UCN2, Drug: PlaceboParticipants will be randomized to investigational drug or placebo |
| Part 3 | Other | Drug: GUB-UCN2, Drug: PlaceboGUB-UCN2 will be investigated as monotherapy and on top of standard of care obesity treatment against placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GUB-UCN2GUB-UCN2 will be administered subcutaneously | Drug | Part 1, Part 2, Part 3 |
| PlaceboPlacebo will be administered subcutaneously | Drug | Part 1, Part 2, Part 3 |
Primary outcome
Number of Treatment Emergent Adverse Events
Time frame: From baseline up to week 22
7 secondary outcomes
AUC(0-∞),SD
Time frame: From baseline up to week 6
AUC(0-last),SD
Time frame: From baseline up to week 6
tmax,SD
Time frame: From baseline up to week 6
Cmax,SD
Time frame: From baseline up to week 6
AUCτ,SS
Time frame: From baseline up to week 22
Cmax, SS
Time frame: From baseline up to week 22
tmax, SS
Time frame: From baseline up to week 22
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing GUB-UCN2 in people with Obesity and Type 2 Diabetes, run by Gubra A/S at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sr. Clinical Trial Manager (+45 3152 2650, drugdevelopment@gubra.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Treatment Emergent Adverse Events (time frame: From baseline up to week 22). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.