ObesityPhase 2NCT06326060
A Research Study Comparing How Well Different Doses of the Medicine NN0519-0130 Help People With Excess Body Weight Lose Weight
A Phase 2 study testing NNC0519-0130 and Tirzepatide in people with Obesity, run by Novo Nordisk A/S at 70 sites in 3 countries.
Trial summary
This study will look at how a new medicine called NNC0519-0130 helps people with excess body weight lose weight. The study will test up to 6 different doses of NNC0519-0130. Participants will take 1-2 injections once a week. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obesity
- What is being tested?
- NNC0519-0130 and Tirzepatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 354 participants
- Where
- 70 sitesin 3 countries
- Study dates
- 18 Mar 2024to 1 May 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female of non-childbearing potential, or male.
- For US only: Female of childbearing potential using highly effective non-systemic methods of contraception with low user-dependency at least 2 months prior to screening and willingness to continue using it through-out the study, or male.
- Age 18-75 years (both inclusive) at the time of signing the informed consent.
- History of at least one self-reported unsuccessful dietary effort to lose body weight.
- a) BMI ≥ 27.0 kg/m2 with the presence of at least one weight-related co-morbidity including, but not limited to, hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease.
- b) BMI ≥ 30.0 kg/m2.
Who cannot join
- HbA1c greater than equal to 6.5% (48 millimoles per mole (mmol/mol)) as measured by the central laboratory at screening.
- History of type 1 or type 2 diabetes mellitus.
- Treatment with any medication prescribed for the indication of obesity or weight management within 90 days before screening.
Trial locations and contacts
70 sites in 3 countries.
70 sites in 3 countries
United States49 sites
Washington Cntr Weight Mgmt
Arlington, Virginia, 22206
Univ of Colorado at Denver
Aurora, Colorado, 80045
Holston Medical Group Pc
Bristol, Tennessee, 37620-7352
Medical University Of South Carolina
Charleston, South Carolina, 29425
Cedar-Crosse Research Center
Chicago, Illinois, 60607
StudyMetrix Research LLC
City of Saint Peters, Missouri, 63303
Velocity Clinical Res
Cleveland, Ohio, 44122
Centennial Medical Group
Columbia, Maryland, 21045
Remington Davis Inc
Columbus, Ohio, 43215
FDRC
Costa Mesa, California, 92627
Nature Coast Clinical Research
Crystal River, Florida, 34429
Baylr Sctt White Rs Inst, Endo
Dallas, Texas, 75226
Velocity Clinical Res-Dallas
Dallas, Texas, 75230
North Texas Endocrine Center
Dallas, Texas, 75231
UT Southwestern Medical Center - Lingvay
Dallas, Texas, 75390
Providence Health Partners Ctr
Dayton, Ohio, 45439
Centricity Research - Ohio
Dublin, Ohio, 43016
Velocity Clin Res Providence
East Greenwich, Rhode Island, 02818
Northeast Research Institute
Fleming Island, Florida, 32003
Medication Mgmnt, LLC_Grnsboro
Greensboro, North Carolina, 27405
PharmQuest Life Sciences LLC
Greensboro, North Carolina, 27408
Physicians East Endocrinology
Greenville, North Carolina, 27834
Midwest Inst For Clin Res
Indianapolis, Indiana, 46260
Jacksonville Ctr For Clin Res
Jacksonville, Florida, 32216
Arkansas Clinical Research
Little Rock, Arkansas, 72205
DCOL Ctr for Clin Res
Longview, Texas, 75605
L-MARC Research Center
Louisville, Kentucky, 40213
Centricity Research-Arizona
Mesa, Arizona, 85206
South Broward Research LLC
Miramar, Florida, 33027
NYU Bariatric Surgical Ctr
New York, New York, 10016
Health Res of Hampton Roads
Newport News, Virginia, 23606
TPMG Clinical Research
Newport News, Virginia, 23606
Lynn Institute of Norman
Norman, Oklahoma, 73072
The University of Penn Center
Philadelphia, Pennsylvania, 19104-3317
Preferred Primary Care Physicians_Pittsburgh
Pittsburgh, Pennsylvania, 15243
National Clin Res Inc.
Richmond, Virginia, 23294
Rochester Clinical Research, Inc.
Rochester, New York, 14609
Unity Health-Searcy Medical Center
Searcy, Arkansas, 72143
Spartanburg Medical Research
Spartanburg, South Carolina, 29303
Encompass Clinical Research_Spring Valley
Spring Valley, California, 91978
Piedmont Healthcare Statesville
Statesville, North Carolina, 28625
Piedmont Healthcare/Research
Statesville, North Carolina, 28625
UCLA Health Southbay Endocrine
Torrance, California, 90505
Velocity Clin. Res Valparaiso
Valparaiso, Indiana, 46383
Velocity Clinical Res. Inc Vestal
Vestal, New York, 13850
Family Practice Center of Wadsworth Inc.
Wadsworth, Ohio, 44281-9236
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598
Accellacare
Wilmington, North Carolina, 28401
Selma Medical Associates
Winchester, Virginia, 22601-3834
Australia19 sites
University of Sunshine Coast
Birtinya, Queensland, 4575
Paratus Clinical
Blacktown, New South Wales, 2148
Northern Beaches Clinical Research
Brookvale, New South Wales, 2100
Paratus Clinical
Bruce, Australian Capital Territory, 2617
Emeritus Research Melbourne
Camberwell, Victoria, 3124
Momentum Clinical Research Darlinghurst
Darlinghurst, New South Wales, 2010
Austin Health, Metabolic Disorders Centre
Heidelberg Heights, Victoria, 3081
Paratus Clinical
Herston, Queensland, 4006
Paratus Clinical
Kanwal, New South Wales, 2259
Novatrials
Kotara, New South Wales, 2289
Sutherland Shire Clinical Research
Miranda, New South Wales, 2228
University of Sunshine Coast
Morayfield, Queensland, 4506
Linear Clinical Research
Nedlands, Western Australia, 6009
CMAX Clinical Research
Norwood, South Australia, 5067
University of Sunshine Coast
Sippy Downs, Queensland, 4556
University of Sunshine Coast
South Brisbane, Queensland, 4101
Momentum Clinical Research
St Albans, Victoria, 3021
Momentum Clinical Research
Taringa, Queensland, 4068
Momentum Clinical Research
Tarragindi, Queensland, 4121
Japan2 sites
OCROM Clinic_Internal medicine
Suita-shi, Osaka, 565-0853
ToCROM Clinic_Internal Medicine
Tokyo, 160-0008
About this study
Official title: Investigation of the Safety and Efficacy of Once Weekly NNC0519-0130 in Participants With Overweight or Obesity - a Dose Finding Study
This study will look at how a new medicine called NNC0519-0130 helps people with excess body weight lose weight. The study will test up to 6 different doses of NNC0519-0130. Participants will take 1-2 injections once a week. The study medicine will be injected under skin with a thin needle in the stomach, thigh, or upper arm. The study will last for about 42 weeks.
- Conditions
- Obesity
- Being tested
- NNC0519-0130, Placebo, Tirzepatide
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NNC0519-0130Drug
NNC0519-0130 will be administered subcutaneously.
PlaceboDrug
Placebo will be administered subcutaneously.
TirzepatideDrug
Tirzepatide will be administered subcutaneously.
| Study group | Role | What they receive |
|---|---|---|
| Dosing scheme a: NNC0519-0130 | Experimental | Participants will receive NNC0519-0130 at 1 dose level subcutaneously (s.c.) once-weekly up to 36 weeks. Receives: Drug: NNC0519-0130 |
| Dosing scheme a: Placebo | Placebo comparator | Participants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks. Receives: Drug: Placebo |
| Dosing scheme b: NNC0519-0130 | Experimental | Participants will receive NNC0519-0130 at 2 dose levels s.c. once-weekly up to 36 weeks. Receives: Drug: NNC0519-0130 |
| Dosing scheme b: Placebo | Placebo comparator | Participants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks. Receives: Drug: Placebo |
| Dosing scheme c: NNC0519-0130 | Experimental | Participants will receive NNC0519-0130 at 3 dose levels s.c. once-weekly up to 36 weeks. Receives: Drug: NNC0519-0130 |
| Dosing scheme c: Placebo | Placebo comparator | Participants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks. Receives: Drug: Placebo |
| Dosing scheme d: NNC0519-0130 | Experimental | Participants will receive NNC0519-0130 at 4 dose levels s.c. once-weekly up to 36 weeks. Receives: Drug: NNC0519-0130 |
| Dosing scheme d: Placebo | Placebo comparator | Participants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks. Receives: Drug: Placebo |
| Dosing scheme e: NNC0519-0130 | Experimental | Participants will receive NNC0519-0130 at 5 dose levels s.c. once-weekly up to 36 weeks. Receives: Drug: NNC0519-0130 |
| Dosing scheme e: Placebo | Placebo comparator | Participants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks. Receives: Drug: Placebo |
| Dosing scheme f: NNC0519-0130 | Experimental | Participants will receive NNC0519-0130 at 6 dose levels s.c. once-weekly up to 36 weeks. Receives: Drug: NNC0519-0130 |
| Dosing scheme f: Placebo | Placebo comparator | Participants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks. Receives: Drug: Placebo |
| Dosing scheme g: Tirzepatide | Active comparator | Participants will receive tirzepatide at 6 dose levels s.c. once weekly up to 36 weeks. Receives: Drug: Tirzepatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative change in body weight
Measured in percentage of body weight.
Measured: From baseline (week 0) to end of treatment (week 36)
Secondary outcomes (20)
Change in body weight
Measured in kilograms (kg)
Measured: From baseline (week 0) to end of treatment (week 36)
Achievement of greater than equal to (≥) 5% weight reduction
Count of participants
Measured: From baseline (week 0) to end of treatment (week 36)
Achievement of ≥ 10% weight reduction
Count of participants
Measured: From baseline (week 0) to end of treatment (week 36)
Achievement of ≥ 15% weight reduction
Count of participants
Measured: From baseline (week 0) to end of treatment (week 36)
Achievement of ≥ 20% weight reduction
Count of participants
Measured: From baseline (week 0) to end of treatment (week 36)
Change in body mass index (BMI)
Measured in Kilogram per meter square (Kg/m^2)
Measured: From baseline (week 0) to end of treatment (week 36)
Change in waist circumference
Measured in centimeter (cm)
Measured: From baseline (week 0) to end of treatment (week 36)
Change in glycated hemoglobin (HbA1c)
Measured in percentage point (%-point)
Measured: From baseline (week 0) to end of treatment (week 36)
Change in fasting plasma glucose (FPG)
Measured in millimoles per liter (mmol/L)
Measured: From baseline (week 0) to end of treatment (week 36)
Change in systolic blood pressure (SBP)
Measured in milliters of mercury (mmHg)
Measured: From baseline (week 0) to end of treatment (week 36)
Change in high sensitivity C-Reactive protein (hsCRP)
Ratio to baseline
Measured: From baseline (week 0) to end of treatment (week 36)
Change in total cholesterol
Ratio to baseline
Measured: From baseline (week 0) to end of treatment (week 36)
Change in high-density lipoprotein (HDL) cholesterol
Ratio to baseline
Measured: From baseline (week 0) to end of treatment (week 36)
Change in low-density lipoprotein (LDL) cholesterol
Ratio to baseline
Measured: From baseline (week 0) to end of treatment (week 36)
Change in triglycerides
Ratio to baseline
Measured: From baseline (week 0) to end of treatment (week 36)
Change in Impact of Weight on Quality of Life-Lite Clinical Trials (IWQOL-Lite-CT) Physical composite score
IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Higher scores indicate better levels of functioning. Total score range is 0-100. Composite score ranges are: physical composite (0-100), psychosocial composite (0-100), and physical function composite (0-100).
Measured: From baseline (week 0) to end of treatment (week 36)
Change in IWQOL-Lite-CT Psychosocial composite score
IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Higher scores indicate better levels of functioning. Total score range is 0-100. Composite score ranges are: physical composite (0-100), psychosocial composite (0-100), and physical function composite (0-100).
Measured: From baseline (week 0) to end of treatment (week 36)
Change in IWQOL-Lite-CT Physical Function score
IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Higher scores indicate better levels of functioning. Total score range is 0-100. Composite score ranges are: physical composite (0-100), psychosocial composite (0-100), and physical function composite (0-100).
Measured: From baseline (week 0) to end of treatment (week 36)
Change in IWQOL-Lite-CT Total score
IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Higher scores indicate better levels of functioning. Total score range is 0-100. Composite score ranges are: physical composite (0-100), psychosocial composite (0-100), and physical function composite (0-100).
Measured: From baseline (week 0) to end of treatment (week 36)
Number of adverse events
Count of events
Measured: From baseline (week 0) to end of treatment (week 40)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start18 Mar 2024
- Primary completion10 Apr 2025
- Study completion1 May 2025
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.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 354 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 2834), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06326060
- Sponsor's protocol ID
- NN9541-5015
- Other IDs
- U1111-1291-9210, jRCT2051230198
- Status last verified
- Apr 2026
- First submitted
- 16 Mar 2024
- Last updated
- 15 Apr 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Safety and Efficacy of Once Weekly NNC0519-0130 in Participants With Overweight or Obesity - a Dose Finding Study
- ClinicalTrials.gov ID
- NCT06326060
- Acronym / sponsor ID
- NN9541-5015
- Conditions
- Obesity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 354 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 18 Mar 2024 (actual)
- Primary completion
- 10 Apr 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 22 Mar 2024 (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.
This study will look at how a new medicine called NNC0519-0130 helps people with excess body weight lose weight. The study will test up to 6 different doses of NNC0519-0130. Participants will take 1-2 injections once a week. The study medicine will be injected under skin with a thin needle in the stomach, thigh, or upper arm. The study will last for about 42 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 13
| Arm | Type | Receives |
|---|---|---|
| Dosing scheme a: NNC0519-0130 | Experimental | Drug: NNC0519-0130Participants will receive NNC0519-0130 at 1 dose level subcutaneously (s.c.) once-weekly up to 36 weeks. |
| Dosing scheme a: Placebo | Placebo comparator | Drug: PlaceboParticipants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks. |
| Dosing scheme b: NNC0519-0130 | Experimental | Drug: NNC0519-0130Participants will receive NNC0519-0130 at 2 dose levels s.c. once-weekly up to 36 weeks. |
| Dosing scheme b: Placebo | Placebo comparator | Drug: PlaceboParticipants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks. |
| Dosing scheme c: NNC0519-0130 | Experimental | Drug: NNC0519-0130Participants will receive NNC0519-0130 at 3 dose levels s.c. once-weekly up to 36 weeks. |
| Dosing scheme c: Placebo | Placebo comparator | Drug: PlaceboParticipants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks. |
| Dosing scheme d: NNC0519-0130 | Experimental | Drug: NNC0519-0130Participants will receive NNC0519-0130 at 4 dose levels s.c. once-weekly up to 36 weeks. |
| Dosing scheme d: Placebo | Placebo comparator | Drug: PlaceboParticipants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks. |
| Dosing scheme e: NNC0519-0130 | Experimental | Drug: NNC0519-0130Participants will receive NNC0519-0130 at 5 dose levels s.c. once-weekly up to 36 weeks. |
| Dosing scheme e: Placebo | Placebo comparator | Drug: PlaceboParticipants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks. |
| Dosing scheme f: NNC0519-0130 | Experimental | Drug: NNC0519-0130Participants will receive NNC0519-0130 at 6 dose levels s.c. once-weekly up to 36 weeks. |
| Dosing scheme f: Placebo | Placebo comparator | Drug: PlaceboParticipants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks. |
| Dosing scheme g: Tirzepatide | Active comparator | Drug: TirzepatideParticipants will receive tirzepatide at 6 dose levels s.c. once weekly up to 36 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female of non-childbearing potential, or male.
- Age 18-75 years (both inclusive) at the time of signing the informed consent.
- History of at least one self-reported unsuccessful dietary effort to lose body weight.
- a) BMI ≥ 27.0 kg/m2 with the presence of at least one weight-related co-morbidity including, but not limited to, hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease.
- b) BMI ≥ 30.0 kg/m2.
Key exclusion criteria (3 listed)
- HbA1c greater than equal to 6.5% (48 millimoles per mole (mmol/mol)) as measured by the central laboratory at screening.
- History of type 1 or type 2 diabetes mellitus.
- Treatment with any medication prescribed for the indication of obesity or weight management within 90 days before screening.
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 |
|---|---|---|
| NNC0519-0130NNC0519-0130 will be administered subcutaneously. | Drug | Dosing scheme a: NNC0519-0130, Dosing scheme b: NNC0519-0130, Dosing scheme c: NNC0519-0130, Dosing scheme d: NNC0519-0130, Dosing scheme e: NNC0519-0130, Dosing scheme f: NNC0519-0130 |
| PlaceboPlacebo will be administered subcutaneously. | Drug | Dosing scheme a: Placebo, Dosing scheme b: Placebo, Dosing scheme c: Placebo, Dosing scheme d: Placebo, Dosing scheme e: Placebo, Dosing scheme f: Placebo |
| TirzepatideTirzepatide will be administered subcutaneously. | Drug | Dosing scheme g: Tirzepatide |
Primary outcome
Relative change in body weight
Time frame: From baseline (week 0) to end of treatment (week 36)
Measured in percentage of body weight.
20 secondary outcomes
Change in body weight
Time frame: From baseline (week 0) to end of treatment (week 36)
Achievement of greater than equal to (≥) 5% weight reduction
Time frame: From baseline (week 0) to end of treatment (week 36)
Achievement of ≥ 10% weight reduction
Time frame: From baseline (week 0) to end of treatment (week 36)
Achievement of ≥ 15% weight reduction
Time frame: From baseline (week 0) to end of treatment (week 36)
Achievement of ≥ 20% weight reduction
Time frame: From baseline (week 0) to end of treatment (week 36)
Change in body mass index (BMI)
Time frame: From baseline (week 0) to end of treatment (week 36)
Change in waist circumference
Time frame: From baseline (week 0) to end of treatment (week 36)
Change in glycated hemoglobin (HbA1c)
Time frame: From baseline (week 0) to end of treatment (week 36)
Change in fasting plasma glucose (FPG)
Time frame: From baseline (week 0) to end of treatment (week 36)
Change in systolic blood pressure (SBP)
Time frame: From baseline (week 0) to end of treatment (week 36)
Change in high sensitivity C-Reactive protein (hsCRP)
Time frame: From baseline (week 0) to end of treatment (week 36)
Change in total cholesterol
Time frame: From baseline (week 0) to end of treatment (week 36)
Change in high-density lipoprotein (HDL) cholesterol
Time frame: From baseline (week 0) to end of treatment (week 36)
Change in low-density lipoprotein (LDL) cholesterol
Time frame: From baseline (week 0) to end of treatment (week 36)
Change in triglycerides
Time frame: From baseline (week 0) to end of treatment (week 36)
Change in Impact of Weight on Quality of Life-Lite Clinical Trials (IWQOL-Lite-CT) Physical composite score
Time frame: From baseline (week 0) to end of treatment (week 36)
Change in IWQOL-Lite-CT Psychosocial composite score
Time frame: From baseline (week 0) to end of treatment (week 36)
Change in IWQOL-Lite-CT Physical Function score
Time frame: From baseline (week 0) to end of treatment (week 36)
Change in IWQOL-Lite-CT Total score
Time frame: From baseline (week 0) to end of treatment (week 36)
Number of adverse events
Time frame: From baseline (week 0) to end of treatment (week 40)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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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. This study is not recruiting at the moment.
Clinical Transparency (dept. 2834) study director
Novo Nordisk A/S
70 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NNC0519-0130 and Tirzepatide in people with Obesity, run by Novo Nordisk A/S at 70 sites in 3 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 6 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: finished, as of the sponsor's last update on 15 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 70 sites in United States, Australia, Japan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative change in body weight (time frame: From baseline (week 0) to end of treatment (week 36)). 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 15 Apr 2026.