ObesityPhase 3AMAZE 12NCT07503210
AMAZE 12: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight Maintain Their Weight Loss
A Phase 3 study testing NNC0487-0111 in people with Obesity, run by Novo Nordisk A/S at 72 sites in 12 countries.
Trial summary
The purpose of this clinical study is to find out if NNC0487-0111 is safe and effective for treating people who have excess body weight. There are 2 study treatments in this study taken as injections under the skin once a week. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- NNC0487-0111
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 606 participants
- Where
- 72 sitesin 12 countries
- Study dates
- 21 Apr 2026to 4 Jul 2028
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female (sex at birth).
- Age 18 years or above at the time of signing the informed consent.
Who cannot join
- Glycated haemoglobin (HbA1c) greater than or 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 as declared by the participant or reported in the medical records.
- Treatment with glucagon-like-peptide-1 (GLP-1) receptor agonists (RA), dual GLP 1/gastric inhibitory peptide (GIP) RAs (or any other GLP-1 based treatment), or amylin analogues before screening.
Trial locations and contacts
72 sites in 12 countries.
72 sites in 12 countries
United States13 sites
Pinnacle Research Group LLC
Anniston, Alabama, 36207
Clinical Res Collaborative
Cumberland, Rhode Island, 02864
North Texas Endocrine Center
Dallas, Texas, 75231
UT Southwestern Med Cntr
Dallas, Texas, 75390-9302
Medication Mgmnt, LLC_Grnsboro
Greensboro, North Carolina, 27405
Midwest Inst For Clin Res
Indianapolis, Indiana, 46260
Florida Inst For Clin Res LLC
Orlando, Florida, 32825
UPA Ctr Weight and Eating Dis
Philadelphia, Pennsylvania, 19104
Rainier Clin Res Ctr Inc
Renton, Washington, 98057
Endeavor Health
Skokie, Illinois, 60077
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598
PMG Research of Wilmington LLC
Wilmington, North Carolina, 28401
Selma Medical Associates
Winchester, Virginia, 22601-3834
Bulgaria8 sites
DCC 1 - Lom EOOD
Lom, 3600
MHAT Med Line Clinic
Plovdiv, 4000
UMHAT Kaspela EOOD, Endocrinology and Metabolic Diseases Clinic
Plovdiv, 4001
AIPSOMCEMD ENDO MED CONSULT 2020 - Dr. Aleksander Botushanov EOOD
Plovdiv, 4002
SGHAT Dr. Shterev EOOD
Sofia, 1330
UMHAT Aleksandrovska EAD, Clinic of Endocrinology and Metabolic Diseases
Sofia, 1431
Medical Center Maraya Med EOOD
Sofia, 1756
AIPSMC Dr. Traykovska EOOD
Sofia, 1839
Italy8 sites
A.O.Universitaria S.ORSOLA-MALPIGHI - U.O.Endocrinologia e Cura
Bologna, 40138
Arcispedale Sant'Anna (Cona) - UO di Endocrinologia
Ferrara, Emilia-Romagna, 44124
IRCCS Ospedale Policlinico San Martino - Medicina Interna e Specialità Mediche
Genoa, Liguria, 16132
Azienda Ospedaliera di Padova - UOSD Chirurgia Bariatrica
Padova, Veneto, 35128
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone - Presidio Villa Belmonte
Palermo, Sicily, 90142
Fondazione Salvatore Maugeri I.R.C.C.S. - Pavia - Dipartimento Medicina Interna e Generale
Pavia, Lombardy, 27100
IRCCS Humanitas - U.O. Endocrinologia e Diabetologia
Rozzano (MI), 20089
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Civile Maggiore Borgo Trento - U.O. Geriatria
Verona, Veneto, 37126
Germany7 sites
Wendisch - Dahl Hamburg - DZHW
Hamburg, 22607
Prof. Dr. Schiefke Ingolf, EUGASTRO GmbH
Leipzig, 04103
Diabetologische Gemeinschaftspraxis Dr. Staudenmeyer und Dr. Schiwietz
Lingen, 49808
Institut für Diabetesforschung GmbH Münster - Dr. med. Rose
Münster, 48145
RED-Institut für medizinische Forschung und Fortbildung GmbH
Oldenburg in Holstein, 23758
Zentrum für klinische Studien Alexander Segner
Saint Ingbert-Oberwürzbach, 66386
Diabetologikum - Diabetologische Schwerpunktpraxis Dr. Thomas Segiet
Speyer, LÄK Rheinland-Pfalz, 67346
Spain7 sites
Centro Periferico De Especialidades Bola Azul
Almería, 04009
Hospital Clinic i Provincial
Barcelona, 08036
H. de León_Endocrinología
León, 24008
Hospital Clínico San Carlos
Madrid, 28040
H. Clinico Univ. Virgen de la Victoria
Málaga, 29010
H.U. Quirónsalud Madrid
Pozuelo de Alarcón, 28223
Hospital Universitario Virgen del Rocío
Seville, 41013
France5 sites
CHU DE CLERMONT-FERRAND-HOPITAL GABRIEL MONTPIED_Service de Nutrition
Clermont-Ferrand, 63000
CHU GRENOBLE ALPES-SITE NORD MICHALLON_Endocrinologie,diabétologie,maladies de la nutrition
La Tronche, 38700
GROUPE SOS SANTE-HOPITAL LE CREUSOT-HOTEL DIEU_ Service de Diabétologie
Le Creusot, 71200
CHU LILLE-HOPITAL CLAUDE HURIEZ_Service de Chirurgie Générale et Endocrinienne
Lille, 59000
CHU DE POITIERS_Centre d'investigation Clinique
Poitiers, 86000
Netherlands5 sites
Progress Clinical Research Den Bosch
's-Hertogenbosch, North Brabant, 5223 LA
EB Flevo Research BV
Almere Stad, 1311RL
Meander MC
Amersfoort, 3813 TZ
Rijnstate Ziekenhuis
Arnhem, 6815 AD
PreCare Trial & Recruitment
Born, Limburg, 6121 XK
Argentina4 sites
CIPREC Pueyrredon
Buenos Aires, C1119ACN
Conexa
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1018ADE
CICEMO- Consultorio (Av Directorio)
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1424CIQ
Instituto de Investigaciones Clinicas Mar Del Plata
Mar del Plata, Buenos Aires, B7600FZN
Australia4 sites
Nightingale Research Adelaide
Adelaide, South Australia, 5000
Sydney Clinical Trials
Campbelltown, New South Wales, 2560
Sydney Cardiometabolic Centre
Liverpool, New South Wales, 2170
Hunter Diabetes Centre
Merewether, New South Wales, 2291
Belgium4 sites
Anima Research Center
Diepenbeek, 3590
AZ Groeninge - Kortrijk - Centrum Endo - Diabetologie
Kortrijk, 8500
Centre hospitalier universitaire de Liège (CHU de Liège)
Liège, 4000
AZ OOSTENDE (Campus DAMIAAN)
Ostend, 8400
United Kingdom4 sites
EMS Healthcare
Macclesfield, North West England, SK10 4TF
Clifton Medical Centre
Rotherham, S65 1DA
Staploe Medical Centre
Soham, CB7 5JD
Albany House Medical Centre
Wellingborough, NN8 4RW
Denmark3 sites
Sydvestjysk Sygehus Esbjerg - Medicinsk Endokrinologisk Ambulatorium, Forskningsenheden
Esbjerg, Region Syddanmark, 6700
Sjællands Universitetshospital, Køge - Medicinsk Afdeling
Køge, Region Sjælland, 4600
Sanos Clinic - Vejle
Vejle, Region Syddanmark, 7100
About this study
Official title: Efficacy and Safety of NNC0487-0111 s.c. Once Weekly in Participants With Obesity Who Have Reached Target Dose During run-in Period (AMAZE 12)
The purpose of this clinical study is to find out if NNC0487-0111 is safe and effective for treating people who have excess body weight. There are 2 study treatments in this study taken as injections under the skin once a week. Participants will either get NNC0487-0111 (the treatment being tested) or Placebo (a treatment that has no active medicine in it). Which treatment participants get is decided by chance.
- Conditions
- Obesity
- Being tested
- NNC0487-0111, Placebo (matched to NNC0487-0111)
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NNC0487-0111Drug
NNC0487-0111 will be administered subcutaneously.
Placebo (matched to NNC0487-0111)Drug
Placebo will be administered subcutaneously.
| Study group | Role | What they receive |
|---|---|---|
| NNC0487-0111 | Experimental | Participants will receive subcutaneous injection of NNC0487-0111 once weekly as an adjunct to a reduced-calorie diet and increased physical activity. Receives: Drug: NNC0487-0111 |
| Placebo | Placebo comparator | Participants will receive subcutaneous injection of placebo matched to NNC0487-0111 once weekly as an adjunct to a reduced-calorie diet and increased physical activity. Receives: Drug: Placebo (matched to NNC0487-0111) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative change in body weight
Measured as percentage (%) of body weight.
Measured: From week 40 to week 92
Secondary outcomes (42)
Relative change in body weight
Measured as % of body weight.
Measured: From week 0 to week 92
Change in waist circumference
Measured as centimetre (cm).
Measured: From week 40 to week 92
Change in systolic blood pressure (SBP)
Measured as millimeter of mercury (mmHg).
Measured: From week 40 to week 92
Change in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) physical function score
Measured as score on a scale. 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. The physical function score ranges from 0-100.
Measured: From week 40 to week 92
Change in SF-36v2® Health Survey Acute (SF-36v2 Acute) physical functioning score
Measured as score on a scale. SF-36v2 Acute measures Health-Related Quality of Life (HRQOL). The measure consists of 36 items yielding 8 health domain scores and 2 component summary scores. SF-36v2 Acute scores are norm-based scores, i.e. transformed to a scale where the 2009 US general population has a mean of 50 and a standard deviation (SD) of 10. Higher scores indicate better functional health and well-being. The physical functioning ranges from 19.0 to 57.6.
Measured: From week 40 to week 92
Change in body weight
Measured as kilogram (kg).
Measured: From week 40 to week 92
Change in body mass index (BMI)
Measured as kilograms per square meter (kg/m^2).
Measured: From week 40 to week 92
Change in body weight
Measured as kg.
Measured: From week 0 to week 92
Change in BMI
Measured as kg/m^2.
Measured: From week 0 to week 92
Change in glycated haemoglobin (HbA1c)
Measured as % of HbA1c.
Measured: From week 40 to week 92
Change in fasting plasma glucose (FPG)
Measured as millimoles per liter (mmol/L).
Measured: From week 40 to week 92
Change in fasting insulin
Measured as ratio to baseline.
Measured: From week 40 to week 92
Change in diastolic blood pressure (DBP)
Measured as mmHg.
Measured: From week 40 to week 92
Change in total cholesterol
Measured as ratio to baseline.
Measured: From week 40 to week 92
Change in High-density lipoprotein (HDL) cholesterol
Measured as ratio to baseline.
Measured: From week 40 to week 92
Change in Low-density lipoprotein (LDL) cholesterol
Measured as ratio to baseline.
Measured: From week 40 to week 92
Change in Very low-density lipoprotein (VLDL) cholesterol
Measured as ratio to baseline.
Measured: From week 40 to week 92
Change in non-HDL cholesterol
Measured as ratio to baseline.
Measured: From week 40 to week 92
Change in triglycerides
Measured as ratio to baseline.
Measured: From week 40 to week 92
Change in high-sensitivity C-reactive protein (hsCRP)
Measured as ratio to baseline.
Measured: From week 40 to week 92
Change in HbA1c
Measured as % of HbA1c.
Measured: From week 0 to week 92
Change in FPG
Measured as mmol/L.
Measured: From week 0 to week 92
Change in fasting insulin
Measured as ratio to baseline.
Measured: From week 0 to week 92
Change in DBP
Measured as mmHg.
Measured: From week 0 to week 92
Change in total cholesterol
Measured as ratio to baseline.
Measured: From week 0 to week 92
Change in HDL cholesterol
Measured as ratio to baseline.
Measured: From week 0 to week 92
Change in LDL cholesterol
Measured as ratio to baseline.
Measured: From week 0 to week 92
Change in VLDL cholesterol
Measured as ratio to baseline.
Measured: From week 0 to week 92
Change in non-HDL cholesterol
Measured as ratio to baseline.
Measured: From week 0 to week 92
Change in triglycerides
Measured as ratio to baseline.
Measured: From week 0 to week 92
Change in hsCRP
Measured as % of hsCRP.
Measured: From week 0 to week 92
Change in waist circumference
Measured as cm.
Measured: From week 0 to week 92
Change in SBP
Measured as mmHg.
Measured: From week 0 to week 92
Change in IWQOL-Lite-CT: physical composite score
Measured as score on a scale. 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. The physical composite score ranges from 0-100.
Measured: From week 40 to week 92
Change in IWQOL-Lite-CT: psychosocial composite score
Measured as score on a scale. 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. The psychosocial composite score ranges from 0-100.
Measured: From week 40 to week 92
Change in IWQOL-Lite-CT: total score
Measured as score on a scale. 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. The total score ranges from 0-100.
Measured: From week 40 to week 92
Number of Treatment Emergent Adverse Events (TEAEs)
Measured as events.
Measured: From week 0 to week 40
Number of Treatment Emergent Serious Adverse Events (TESAEs)
Measured as events.
Measured: From week 0 to week 40
Number of TEAEs leading to permanent treatment discontinuation
Measured as events.
Measured: From week 0 to week 40
Number of TEAEs
Measured as events.
Measured: From week 40 to week 96
Number of TESAEs
Measured as events.
Measured: From week 40 to week 96
Number of TEAEs leading to permanent treatment discontinuation
Measured as events.
Measured: From week 40 to week 96
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2026
- Study start21 Apr 2026
- Primary completion6 Jun 2028 (estimated)
- Study completion4 Jul 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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 606 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
- NCT07503210
- Sponsor's protocol ID
- NN9490-8559
- Other IDs
- U1111-1327-1477, 2025-523804-62, 2025
- Acronym
- AMAZE 12
- Status last verified
- Sep 2026
- First submitted
- 25 Mar 2026
- Last updated
- 11 Sep 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
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of NNC0487-0111 s.c. Once Weekly in Participants With Obesity Who Have Reached Target Dose During run-in Period (AMAZE 12)
- ClinicalTrials.gov ID
- NCT07503210
- Acronym / sponsor ID
- AMAZE 12 / NN9490-8559
- Conditions
- Obesity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 606 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 21 Apr 2026 (actual)
- Primary completion
- 6 Jun 2028 (estimated)
- Study completion
- 4 Jul 2028 (estimated)
- First posted
- 31 Mar 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 purpose of this clinical study is to find out if NNC0487-0111 is safe and effective for treating people who have excess body weight. There are 2 study treatments in this study taken as injections under the skin once a week. Participants will either get NNC0487-0111 (the treatment being tested) or Placebo (a treatment that has no active medicine in it). Which treatment participants get is decided by chance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NNC0487-0111 | Experimental | Drug: NNC0487-0111Participants will receive subcutaneous injection of NNC0487-0111 once weekly as an adjunct to a reduced-calorie diet and increased physical activity. |
| Placebo | Placebo comparator | Drug: Placebo (matched to NNC0487-0111)Participants will receive subcutaneous injection of placebo matched to NNC0487-0111 once weekly as an adjunct to a reduced-calorie diet and increased physical activity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female (sex at birth).
- Age 18 years or above at the time of signing the informed consent.
Key exclusion criteria (3 listed)
- Glycated haemoglobin (HbA1c) greater than or 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 as declared by the participant or reported in the medical records.
- Treatment with glucagon-like-peptide-1 (GLP-1) receptor agonists (RA), dual GLP 1/gastric inhibitory peptide (GIP) RAs (or any other GLP-1 based treatment), or amylin analogues 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 |
|---|---|---|
| NNC0487-0111NNC0487-0111 will be administered subcutaneously. | Drug | NNC0487-0111 |
| Placebo (matched to NNC0487-0111)Placebo will be administered subcutaneously. | Drug | Placebo |
Primary outcome
Relative change in body weight
Time frame: From week 40 to week 92
Measured as percentage (%) of body weight.
42 secondary outcomes
Relative change in body weight
Time frame: From week 0 to week 92
Change in waist circumference
Time frame: From week 40 to week 92
Change in systolic blood pressure (SBP)
Time frame: From week 40 to week 92
Change in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) physical function score
Time frame: From week 40 to week 92
Change in SF-36v2® Health Survey Acute (SF-36v2 Acute) physical functioning score
Time frame: From week 40 to week 92
Change in body weight
Time frame: From week 40 to week 92
Change in body mass index (BMI)
Time frame: From week 40 to week 92
Change in body weight
Time frame: From week 0 to week 92
Change in BMI
Time frame: From week 0 to week 92
Change in glycated haemoglobin (HbA1c)
Time frame: From week 40 to week 92
Change in fasting plasma glucose (FPG)
Time frame: From week 40 to week 92
Change in fasting insulin
Time frame: From week 40 to week 92
Change in diastolic blood pressure (DBP)
Time frame: From week 40 to week 92
Change in total cholesterol
Time frame: From week 40 to week 92
Change in High-density lipoprotein (HDL) cholesterol
Time frame: From week 40 to week 92
Change in Low-density lipoprotein (LDL) cholesterol
Time frame: From week 40 to week 92
Change in Very low-density lipoprotein (VLDL) cholesterol
Time frame: From week 40 to week 92
Change in non-HDL cholesterol
Time frame: From week 40 to week 92
Change in triglycerides
Time frame: From week 40 to week 92
Change in high-sensitivity C-reactive protein (hsCRP)
Time frame: From week 40 to week 92
Change in HbA1c
Time frame: From week 0 to week 92
Change in FPG
Time frame: From week 0 to week 92
Change in fasting insulin
Time frame: From week 0 to week 92
Change in DBP
Time frame: From week 0 to week 92
Change in total cholesterol
Time frame: From week 0 to week 92
Change in HDL cholesterol
Time frame: From week 0 to week 92
Change in LDL cholesterol
Time frame: From week 0 to week 92
Change in VLDL cholesterol
Time frame: From week 0 to week 92
Change in non-HDL cholesterol
Time frame: From week 0 to week 92
Change in triglycerides
Time frame: From week 0 to week 92
Change in hsCRP
Time frame: From week 0 to week 92
Change in waist circumference
Time frame: From week 0 to week 92
Change in SBP
Time frame: From week 0 to week 92
Change in IWQOL-Lite-CT: physical composite score
Time frame: From week 40 to week 92
Change in IWQOL-Lite-CT: psychosocial composite score
Time frame: From week 40 to week 92
Change in IWQOL-Lite-CT: total score
Time frame: From week 40 to week 92
Number of Treatment Emergent Adverse Events (TEAEs)
Time frame: From week 0 to week 40
Number of Treatment Emergent Serious Adverse Events (TESAEs)
Time frame: From week 0 to week 40
Number of TEAEs leading to permanent treatment discontinuation
Time frame: From week 0 to week 40
Number of TEAEs
Time frame: From week 40 to week 96
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 11 Sep 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
72 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing NNC0487-0111 in people with Obesity, run by Novo Nordisk A/S at 72 sites in 12 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 2 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: under way, not looking for participants, as of the sponsor's last update on 11 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 72 sites in United States, Bulgaria, Italy, Germany, Spain and 7 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
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 week 40 to week 92). 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 11 Sep 2026.