Obesity DiseasePhase 3MARITIME-3-JNCT06987695
Efficacy and Safety of Maridebart Cafraglutide in Adult Participants in Japan Who Have Obesity Disease
A Phase 3 study testing Maridebart cafraglutide in people with Obesity Disease, run by Amgen at 30 sites in Japan.
Trial summary
The primary objective of this study is to demonstrate that maridebart cafraglutide is superior to placebo for percent change in body weight and proportion of participants with ≥ 5% reduction in body weight. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Obesity Disease
- What is being tested?
- Maridebart cafraglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 279 participants
- Where
- 30 sitesJapan
- Study dates
- 13 Jun 2025to 21 Jul 2027
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- History of at least 1 self-reported unsuccessful attempt at weight loss by diet and exercise.
- Body mass index (BMI) ≥ 35 kg/m^2 at screening with a current diagnosis of at least 1 of the weigh-related comorbidities specified in the Japan Society for the Study of Obesity (JASSO) guideline OR BMI ≥ 27 kg/m^2 to < 35 kg/m^2 at screening, with a current diagnosis of at least 2 of the weight-related comorbidities specified in the JASSO guideline.
- For both BMI categories, at least 1 of the weight-related comorbidities must be hypertension, dyslipidemia, or T2DM according to the definitions below:
- hypertension: treated, or with SBP ≥ 140 mmHg, or DBP ≥ 90 mmHg at screening.
- dyslipidemia: treated, or with LDL > 140 mg/dL (3.6 mmol/L), or triglycerides ≥ 150 mg/dL (1.7 mmol/L), or non-HDL cholesterol > 170 mg/dL (4.4 mmol/L) or HDL < 40 mg/dL (1.0 mmol/L) at screening.
Show all 10Show fewer
- T2DM: diagnosed ≥ 180 days before screening, and treated with diet and exercise alone and/or a stable treatment for at least 90 days before screening with up to 3 oral glucose-lowering medications (as per local labeling) (except for glucagon-like peptide-1 receptor agonists [GLP-1RA] and dipeptidyl peptidase-4 [DPP-4] inhibitors), and have a HbA1c ≥ 7% and ≤ 10% (53-86 mmol/mol) at screening.
- In the opinion of the investigator, well-motivated and willing to:
- Follow study procedures for the duration of the study, including, but not limited to, follow lifestyle advice, maintain a study log(s)/diary(ies), and complete required study visits and questionnaires.
- Perform self-monitoring blood glucose (SMBG) per protocol (only for participants with T2DM).
Who cannot join
- Obesity induced by other endocrinological disorders or monogenetic or syndromic forms of obesity.
- Self-reported change in body weight > 5 kg within 90 days before screening.
- Previous or planned (during the study) surgical, endoscopic, or device-based treatment for obesity.
- For participants without diabetes at screening, type 1 or 2 diabetes mellitus or any other types of diabetes mellitus (except history of gestational diabetes).
- For participants with T2DM at screening, any other type(s) of diabetes mellitus except T2DM.
- History of chronic pancreatitis or history of acute pancreatitis within 180 days before screening.
Show all 9Show fewer
- Family (first-degree relative[s]) or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2).
- History of unstable major depressive disorder (MDD) or other severe psychiatric disorder within 2 years before screening.
- Lifetime history of suicide attempt.
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
Japan30 sites
Adachi Kyosai Hospital
Adachi-ku, Tokyo, 120-0022
Aira Diabetes Thyroid Internal Medicine Clinic
Aira-shi, Kagoshima-ken, 899-5421
Yamasaki Family Clinic
Amagasaki-shi, Hyōgo, 660-0861
Nihonbashi Sakura Clinic
Chuo-ku, Tokyo, 103-0025
Medical Corporation Chiseikai Tokyo Center Clinic
Chuo-ku, Tokyo, 103-0027
Wellness Tenjin Clinic
Fukuoka, Fukuoka, 810-0001
Medical Corporation Boocs Boocs Clinic Fukuoka
Fukuoka, Fukuoka, 812-0025
Kyushu University Hospital
Fukuoka, Fukuoka, 812-8582
Tashiro Endocrinology Clinic
Fukuoka, Fukuoka, 814-0153
Medical Corporation Kenshinkai Minamino Cardiovascular Hospital
Hachioji-shi, Tokyo, 192-0918
Matsunami Health Promotion Clinic
Hashima-gun, Gifu, 501-6061
Matsuba Clinic
Kawasaki-shi, Kanagawa, 212-0024
Kobe University Hospital
Kobe, Hyōgo, 650-0017
Deguchi Clinic
Kobe, Hyōgo, 652-0803
Medical Corporation Keiseikai Kajiyama Clinic
Kyoto, Kyoto, 600-8898
Kyoto University Hospital
Kyoto, Kyoto, 606-8507
Tokyo Saiseikai Central Hospital
Minato-ku, Tokyo, 108-0073
Midori Clinic
Nagasaki, Nagasaki, 852-8034
Meitetsu Hospital
Nagoya, Aichi-ken, 451-8511
Hosokawa Surgical Clinic
Nagoya, Aichi-ken, 453-0812
Social Medical Corporation Kojunkai Daido Clinic
Nagoya, Aichi-ken, 457-8511
Nishiyamado Keiwa Hospital
Naka, Ibaraki, 311-0133
Shimamura Memorial Hospital
Nerima-ku, Tokyo, 177-0051
Fukuoka Shinmizumaki Hospital
Onga-gun, Fukuoka, 807-0051
Joh Medical Clinic
Osaka, Osaka, 530-0002
Manda Memorial Hospital
Sapporo, Hokkaido, 060-0062
MIH Clinic Yoyogi
Shibuya-ku, Tokyo, 151-0051
Shinjuku Southern Clinic
Shinjuku-ku, Tokyo, 160-0023
Ikebukuro Metropolitan Clinic
Toshima-ku, Tokyo, 171-0021
Urasoe General Hospital
Urasoe-shi, Okinawa, 901-2102
About this study
Official title: A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Maridebart Cafraglutide in Adult Participants in Japan Who Have Obesity Disease (MARITIME 3-J)
The primary objective of this study is to demonstrate that maridebart cafraglutide is superior to placebo for percent change in body weight and proportion of participants with ≥ 5% reduction in body weight.
- Conditions
- Obesity Disease
- Being tested
- Maridebart cafraglutide, Placebo
- Keywords
- Overweight, BMI, Body weight, Maridebart cafraglutide, Chronic weight management, MariTide, Type 2 Diabetes Mellitus, T2DM
- Medical subject headings
- Overweight, Body Weight, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maridebart cafraglutideDrug
Also called AMG 133, MariTide
Maridebart cafraglutide will be administered SC.
PlaceboDrug
Placebo will be administered SC.
| Study group | Role | What they receive |
|---|---|---|
| Maridebart Cafraglutide High Dose | Experimental | Participants will receive maridebart cafraglutide high dose subcutaneously (SC) for 72 weeks. Receives: Drug: Maridebart cafraglutide |
| Maridebart Cafraglutide Medium Dose | Experimental | Participants will receive maridebart cafraglutide medium dose SC for 72 weeks. Receives: Drug: Maridebart cafraglutide |
| Maridebart Cafraglutide Low Dose | Experimental | Participants will receive maridebart cafraglutide low dose SC for 72 weeks. Receives: Drug: Maridebart cafraglutide |
| Placebo | Placebo comparator | Participants will receive placebo SC for 72 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline in Body Weight at Week 72
Measured: Baseline and Week 72
Participants Achieving ≥ 5% Reduction in Body Weight From Baseline at Week 72
Measured: Baseline and Week 72
Secondary outcomes (30)
Change From Baseline in Waist Circumference at Week 72
Measured: Baseline and Week 72
Participants Achieving ≥ 10% Reduction in Body Weight from Baseline at Week 72
Measured: Baseline and Week 72
Participants Achieving ≥ 15% Reduction in Body Weight from Baseline at Week 72
Measured: Baseline and Week 72
Change From Baseline in Body Weight at Week 72
Measured: Baseline and Week 72
Percent Change From Baseline in Body Weight in Participants Without Type 2 Diabetes Mellitus (T2DM) at Week 72
Measured: Baseline and Week 72
Percent Change From Baseline in Body Weight in Participants With T2DM at Week 72
Measured: Baseline and Week 72
Change From Baseline in Body Mass Index (BMI) at Week 72
Measured: Baseline and Week 72
Participants Achieving ≥ 20% Reduction in Body Weight from Baseline at Week 72
Measured: Baseline and Week 72
Change From Baseline in Visceral Fat Area (VFA) at Week 72
Measured: Baseline and Week 72
Participants Achieving VFA < 100 cm^2 in VFA at Week 72
Measured: Week 72
Percent Change From Baseline in Fasting Total Cholesterol at Week 72
Measured: Baseline and Week 72
Percent Change From Baseline in Fasting Non-high-density Lipoprotein Cholesterol (non-HDL-C) at Week 72
Measured: Baseline and Week 72
Percent Change From Baseline in Fasting Low-density Lipoprotein Cholesterol (LDL-C) at Week 72
Measured: Baseline and Week 72
Percent Change From Baseline in Fasting Triglycerides at Week 72
Measured: Baseline and Week 72
Percent Change From Baseline in Fasting Very Low-density Lipoprotein Cholesterol (VLDL-C) at Week 72
Measured: Baseline and Week 72
Percent Change From Baseline in Fasting High-density Lipoprotein Cholesterol (HDL-C) at Week 72
Measured: Baseline and Week 72
Change From Baseline in Systolic Blood Pressure (SBP) at Week 72
Measured: Baseline and Week 72
Change From Baseline in Diastolic Blood Pressure (DBP) at Week 72
Measured: Baseline and Week 72
Change From Baseline in Fasting Plasma Glucose at Week 72
Measured: Baseline and Week 72
Percent Change From Baseline in Fasting Insulin at Week 72
Measured: Baseline and Week 72
Change from Baseline in Hemoglobin A1c (HbA1c) at Week 72
Measured: Baseline and Week 72
Percentage of Participants with a Change from Baseline in Glycemic Status at Week 72 for Participants Without T2DM at Baseline
Glycemic status was categorized as:
- normoglycemic (fasting plasma glucose < 100 mg/dL and HbA1c < 5.7%, in absence of T2DM diagnosis),
- prediabetes (fasting plasma glucose 100 - 125 mg/dL or HbA1c 5.7% - 6.4% in the absence of a T2DM diagnosis),
- or, T2DM (fasting plasma glucose ≥ 126 mg/dL and HbA1c ≥6.5%).
Measured: Baseline and Week 72
Participants With T2DM Achieving HbA1c < 7% at Week 72
Measured: Week 72
Participants With T2DM Achieving HbA1c ≤ 6.5% at Week 72
Measured: Week 72
Participants With T2DM Achieving HbA1c < 5.7% at Week 72
Measured: Week 72
Change From Baseline in Short Form 36 Health Survey Version 2 (SF-36v2) Acute Physical Function Domain Score at Week 72
The SF-36v2 Acute Physical Function domain score measures an individual's ability to perform daily physical activities, such as walking and climbing stairs, over the past week. It includes 10 items scored on a 3-point Likert scale, with raw scores transformed to a 0-100 scale. Higher scores indicate better physical functioning and fewer limitations due to physical health.
Measured: Baseline and Week 72
Change from Baseline in the Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score at Week 72
The IWQOL-Lite-CT is a 20-item questionnaire designed to assess the impact of weight on quality of life in clinical trials. Items are scored on a 5-point Likert scale, with raw scores transformed to a 0-100 scale, where higher scores indicate better quality of life and less weight-related impact.
Measured: Baseline and Week 72
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Measured: Up to Week 84
Number of Participants Experiencing Serious Adverse Events
Measured: Up to Week 84
Plasma Concentration of Maridebart Cafraglutide at Week 72
Measured: Week 72
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2025
- Study start13 Jun 2025
- Primary completion27 Apr 2027 (estimated)
- Study completion21 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity DiseaseStudies of the same condition, open and under way.
- More trials run by AmgenThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 279 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06987695
- Sponsor's protocol ID
- 20230144
- Acronym
- MARITIME-3-J
- Status last verified
- Dec 2025
- First submitted
- 2 May 2025
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Maridebart Cafraglutide in Adult Participants in Japan Who Have Obesity Disease (MARITIME 3-J)
- ClinicalTrials.gov ID
- NCT06987695
- Acronym / sponsor ID
- MARITIME-3-J / 20230144
- Conditions
- Obesity Disease
- Keywords
- Overweight, BMI, Body weight, Maridebart cafraglutide, Chronic weight management, MariTide, Type 2 Diabetes Mellitus, T2DM
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 279 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 13 Jun 2025 (actual)
- Primary completion
- 27 Apr 2027 (estimated)
- Study completion
- 21 Jul 2027 (estimated)
- First posted
- 23 May 2025 (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 primary objective of this study is to demonstrate that maridebart cafraglutide is superior to placebo for percent change in body weight and proportion of participants with ≥ 5% reduction in body weight.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Maridebart Cafraglutide High Dose | Experimental | Drug: Maridebart cafraglutideParticipants will receive maridebart cafraglutide high dose subcutaneously (SC) for 72 weeks. |
| Maridebart Cafraglutide Medium Dose | Experimental | Drug: Maridebart cafraglutideParticipants will receive maridebart cafraglutide medium dose SC for 72 weeks. |
| Maridebart Cafraglutide Low Dose | Experimental | Drug: Maridebart cafraglutideParticipants will receive maridebart cafraglutide low dose SC for 72 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive placebo SC for 72 weeks. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥ 18 years.
- History of at least 1 self-reported unsuccessful attempt at weight loss by diet and exercise.
- Body mass index (BMI) ≥ 35 kg/m^2 at screening with a current diagnosis of at least 1 of the weigh-related comorbidities specified in the Japan Society for the Study of Obesity (JASSO) guideline OR BMI ≥ 27 kg/m^2 to < 35 kg/m^2 at screening, with a current diagnosis of at least 2 of the weight-related comorbidities specified in the JASSO guideline.
- For both BMI categories, at least 1 of the weight-related comorbidities must be hypertension, dyslipidemia, or T2DM according to the definitions below:
- In the opinion of the investigator, well-motivated and willing to:
Key exclusion criteria (9 listed)
- Obesity induced by other endocrinological disorders or monogenetic or syndromic forms of obesity.
- Self-reported change in body weight > 5 kg within 90 days before screening.
- Previous or planned (during the study) surgical, endoscopic, or device-based treatment for obesity.
- For participants without diabetes at screening, type 1 or 2 diabetes mellitus or any other types of diabetes mellitus (except history of gestational diabetes).
- For participants with T2DM at screening, any other type(s) of diabetes mellitus except T2DM.
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 |
|---|---|---|
| Maridebart cafraglutideAlso: AMG 133, MariTideMaridebart cafraglutide will be administered SC. | Drug | Maridebart Cafraglutide High Dose, Maridebart Cafraglutide Low Dose, Maridebart Cafraglutide Medium Dose |
| PlaceboPlacebo will be administered SC. | Drug | Placebo |
Primary outcome
Percent Change From Baseline in Body Weight at Week 72
Time frame: Baseline and Week 72
Participants Achieving ≥ 5% Reduction in Body Weight From Baseline at Week 72
Time frame: Baseline and Week 72
30 secondary outcomes
Change From Baseline in Waist Circumference at Week 72
Time frame: Baseline and Week 72
Participants Achieving ≥ 10% Reduction in Body Weight from Baseline at Week 72
Time frame: Baseline and Week 72
Participants Achieving ≥ 15% Reduction in Body Weight from Baseline at Week 72
Time frame: Baseline and Week 72
Change From Baseline in Body Weight at Week 72
Time frame: Baseline and Week 72
Percent Change From Baseline in Body Weight in Participants Without Type 2 Diabetes Mellitus (T2DM) at Week 72
Time frame: Baseline and Week 72
Percent Change From Baseline in Body Weight in Participants With T2DM at Week 72
Time frame: Baseline and Week 72
Change From Baseline in Body Mass Index (BMI) at Week 72
Time frame: Baseline and Week 72
Participants Achieving ≥ 20% Reduction in Body Weight from Baseline at Week 72
Time frame: Baseline and Week 72
Change From Baseline in Visceral Fat Area (VFA) at Week 72
Time frame: Baseline and Week 72
Participants Achieving VFA < 100 cm^2 in VFA at Week 72
Time frame: Week 72
Percent Change From Baseline in Fasting Total Cholesterol at Week 72
Time frame: Baseline and Week 72
Percent Change From Baseline in Fasting Non-high-density Lipoprotein Cholesterol (non-HDL-C) at Week 72
Time frame: Baseline and Week 72
Percent Change From Baseline in Fasting Low-density Lipoprotein Cholesterol (LDL-C) at Week 72
Time frame: Baseline and Week 72
Percent Change From Baseline in Fasting Triglycerides at Week 72
Time frame: Baseline and Week 72
Percent Change From Baseline in Fasting Very Low-density Lipoprotein Cholesterol (VLDL-C) at Week 72
Time frame: Baseline and Week 72
Percent Change From Baseline in Fasting High-density Lipoprotein Cholesterol (HDL-C) at Week 72
Time frame: Baseline and Week 72
Change From Baseline in Systolic Blood Pressure (SBP) at Week 72
Time frame: Baseline and Week 72
Change From Baseline in Diastolic Blood Pressure (DBP) at Week 72
Time frame: Baseline and Week 72
Change From Baseline in Fasting Plasma Glucose at Week 72
Time frame: Baseline and Week 72
Percent Change From Baseline in Fasting Insulin at Week 72
Time frame: Baseline and Week 72
Change from Baseline in Hemoglobin A1c (HbA1c) at Week 72
Time frame: Baseline and Week 72
Percentage of Participants with a Change from Baseline in Glycemic Status at Week 72 for Participants Without T2DM at Baseline
Time frame: Baseline and Week 72
Participants With T2DM Achieving HbA1c < 7% at Week 72
Time frame: Week 72
Participants With T2DM Achieving HbA1c ≤ 6.5% at Week 72
Time frame: Week 72
Participants With T2DM Achieving HbA1c < 5.7% at Week 72
Time frame: Week 72
Change From Baseline in Short Form 36 Health Survey Version 2 (SF-36v2) Acute Physical Function Domain Score at Week 72
Time frame: Baseline and Week 72
Change from Baseline in the Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score at Week 72
Time frame: Baseline and Week 72
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to Week 84
Number of Participants Experiencing Serious Adverse Events
Time frame: Up to Week 84
Plasma Concentration of Maridebart Cafraglutide at Week 72
Time frame: Week 72
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 17 Dec 2025.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Related trials for Obesity Disease
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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.
MD study director
Amgen
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Maridebart cafraglutide in people with Obesity Disease, run by Amgen at 30 sites in Japan.
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 10 inclusion and 9 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 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in 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 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?
Percent Change From Baseline in Body Weight at Week 72 (time frame: Baseline and Week 72). The study lists 2 primary outcomes in all. 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 17 Dec 2025.