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OverweightPhase 2NCT07395687

A Research Study on How Well Different Doses of the Medicine UBT251 Help People Living With Overweight or Obesity

A Phase 2 study testing UBT251 in people with Overweight and Obesity, run by Novo Nordisk A/S at 3 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The purpose of this clinical study is to find out if UBT251 is safe and effective for treating people who are living with overweight or obesity. Participants will get either UBT251 (the treatment being tested) or Placebo (a treatment that has no active medicine in it), which treatment participants get is decided by… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Overweight, Obesity
What is being tested?
UBT251
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
333 participants
Where
3 sitesin 2 countries
Study dates
2 Feb 2026to 18 Feb 2027
Phase
Phase 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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female (sex at birth).
  • For Part C: Japanese, Chinese or non-Asian participants (all self-reported):
  • For Japanese participants: both parents of Japanese descent.
  • For Chinese participants: both parents of Chinese descent.
  • For non-Asian participants: both parents of non-Asian descent (non-Asian is defined as of countries outside of Asia).
  • Age at the time of signing the informed consent:
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  • For Part A: 18-55 years (both inclusive)
  • For Part B: 18-65 years (both inclusive)
  • For Part C: 18-55 years (both inclusive).
  • BMI at screening (overweight and obesity should be due to excess adipose tissue, as judged by the investigator):
  • For Part A: 27.0-39.9 kilogram per meter square (kg/m^2) (both inclusive)
  • For Part B: 30.0-50.0 kg/m^2 (both inclusive)
  • For Part C: 24-34.9 kg/m^2 (both inclusive)
  • Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG), and clinical laboratory tests performed during the screening visit, as judged by the investigator.

Who cannot join

  • Known or suspected hypersensitivity to study intervention(s) or related products.
  • Treatment with any marketed product containing compounds with glucagon-like peptide 1 (GLP-1), glucose-dependent insulinotropic polypeptide (GIP) or glucagon receptor agonism within 90 days before screening.
  • Any condition, unwillingness or inability, which in the investigator's opinion might jeopardise the participant's safety or compliance with the protocol.

Trial locations and contacts

3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Novo Nordisk contact

(+1) 866-867-7178

clinicaltrials@novonordisk.com

3 sites in 2 countries

United States2 sites, 2 recruiting

  • Altasciences Clinical LA, Inc.

    Cypress, California, 90630

    Recruiting

  • Altasciences Clinical Kansas, Inc.

    Overland Park, Kansas, 66212

    Recruiting

Other trials in United States

Canada1 site, 1 recruiting

  • Altasciences Clinical Company, Inc

    Montreal, Quebec, H3P 3P1

    Recruiting

Other trials in Canada

About this study

Official title: A Study Investigating Safety, Tolerability and Efficacy of UBT251 in Participants Living With Overweight or Obesity

The purpose of this clinical study is to find out if UBT251 is safe and effective for treating people who are living with overweight or obesity. Participants will get either UBT251 (the treatment being tested) or Placebo (a treatment that has no active medicine in it), which treatment participants get is decided by chance.

Conditions
Overweight, Obesity
Being tested
UBT251, Placebo
Medical subject headings
Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • UBT251Drug

    UBT251 injection will be administered subcutaneously in a lifted fold of the abdominal skin.

  • PlaceboDrug

    Placebo matched to UBT251 injection will be administered subcutaneously in a lifted fold of the abdominal skin.

Study groups in NCT07395687
Study groupRoleWhat they receive
Part A - UBT251ExperimentalParticipants will be randomized to receive multiple dose levels subcutaneously.
Receives: Drug: UBT251
Part A - placeboPlacebo comparatorParticipants will receive placebo matched to UBT251 subcutaneously.
Receives: Drug: Placebo
Part B - Arm A (UBT251)ExperimentalParticipants will be randomized to receive multiple dose levels subcutaneously.
Receives: Drug: UBT251
Part B - Arm B (UBT251)ExperimentalParticipants will be randomized to receive multiple dose levels subcutaneously.
Receives: Drug: UBT251
Part B - Arm C (UBT251)ExperimentalParticipants will be randomized to receive multiple dose levels subcutaneously.
Receives: Drug: UBT251
Part B - Arm D (UBT251)ExperimentalParticipants will be randomized to receive 2 dose levels subcutaneously.
Receives: Drug: UBT251
Part B - Arm E (UBT251)ExperimentalParticipants will be randomized to receive a single dose level subcutaneously.
Receives: Drug: UBT251
Part B - placeboPlacebo comparatorParticipants will receive placebo matching one of the UBT251 arms subcutaneously.
Receives: Drug: Placebo
Part C - UBT251 dose 1ExperimentalParticipants will be randomized to receive dose level 1 subcutaneously.
Receives: Drug: UBT251
Part C - UBT251 dose 2ExperimentalParticipants will be randomized to receive dose level 2 subcutaneously.
Receives: Drug: UBT251
Part C - UBT251 dose 3ExperimentalParticipants will be randomized to receive dose level 3 subcutaneously.
Receives: Drug: UBT251

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part A - Number of treatment emergent adverse events (TEAEs)

    Measured as Number of events.

    Measured: From baseline (week 0) to end of study (week 33)

  2. Part B - Relative change in body weight

    Measured as percentage of body weight.

    Measured: From baseline (week 0) to end of treatment (week 28)

  3. Part C- AUC; the area under the UBT251 plasma concentration time curve

    Measured as hour*nanomoles per liter (h*nmol/L)

    Measured: From pre-dose on Day 1 until completion of the end of study visit (Day 43)

Secondary outcomes (9)

  1. Part A - Relative change in body weight

    Measured as percentage of body weight.

    Measured: From baseline (week 0) to end of treatment (week 28)

  2. Part A - Change in body weight

    Measured as kilogram (kg).

    Measured: From baseline (week 0) to end of treatment (week 28)

  3. Part A - AUC; the area under the UBT251 plasma concentration-time curve

    Measured as h*nmol/L

    Measured: From pre-dose on day 1 to end of study (week 33)

  4. Part A - Cmax; the maximum plasma concentration of UBT251

    Measured as nanomole per liter (nmol/L)

    Measured: From pre-dose on day 1 to end of study (week 33)

  5. Part B - Change in body weight

    Measured as kg.

    Measured: From baseline (week 0) to end of treatment (week 28)

  6. Part B - Change in waist circumference

    Measured as centimetre (cm).

    Measured: From baseline (week 0) to end of treatment (week 28)

  7. Part B - Number of TEAEs

    Measured as number of events

    Measured: From baseline (week 0) to end of study (week 33)

  8. Part C - Cmax; the maximum plasma concentration of UBT251

    Measured as nmol/L

    Measured: From pre-dose on Day 1 until completion of the end of study visit (Day 43)

  9. Part C - Number of treatment-emergent adverse events (TEAEs)

    Measured as number of events.

    Measured: From pre-dose on Day 1 until completion of the end of study visit (Day 43)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Feb 2026
  2. Study start2 Feb 2026
  3. Primary completion14 Jan 2027 (estimated)
  4. Study completion18 Feb 2027 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
333 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07395687
Sponsor's protocol ID
NN9559-8568
Other IDs
U1111-1324-3831
Status last verified
Apr 2026
First submitted
1 Feb 2026
Last updated
21 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing UBT251 in people with Overweight and Obesity, run by Novo Nordisk A/S at 3 sites in 2 countries.

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 14 inclusion and 3 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 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States, Canada. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

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 Novo Nordisk ((+1) 866-867-7178, clinicaltrials@novonordisk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A - Number of treatment emergent adverse events (TEAEs) (time frame: From baseline (week 0) to end of study (week 33)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07395687.

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 21 Apr 2026.

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