Obesity or OverweightPhase 3SELENE 3NCT07776509

A Study to Evaluate Effect of AZD6234 as an Adjunct to Incretin-based Therapies in Adult Participants With Obesity or Overweight With Weight-related Comorbidity With or Without Type 2 Diabetes Mellitus

A Phase 3 study testing Lenbelintide in people with Obesity or Overweight and Weight-Related Comorbidity, run by AstraZeneca at 96 sites in 11 countries.

Recruiting

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

Sites and contacts

Official record

Search all trials

Trial summary

The study will evaluate how well AZD6234 works and how safe it is in adults with excess weight or obesity. Efficacy of AZD6234 will be compared to placebo in percent body weight change from baseline at 68 weeks of treatment. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Obesity or Overweight, Weight-Related Comorbidity, With/Without Diabetes Mellitus, Type 2
What is being tested?: Lenbelintide
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 500 participants
Where: 96 sitesin 11 countries
Study dates: 24 Aug 2026to 9 Aug 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

Males \& females (inclusive of all gender identities) age ≥18 years
BMI ≥ 30 kg/m2 OR BMI ≥ 27 kg/m2 with at least one of the following weight-related comorbidities (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea, cardiovascular disease, heart failure, chronic kidney disease, metabolic dysfunction associated steatotic liver disease, osteoarthritis of the knee, or stress urinary incontinence
For participants with T2DM only:
Diagnosed with T2DM ≥ 90 days prior to Screening
HbA1c value at Screening of ≥6.0% (42 mmol/mol) and ≤9.0% (75 mmol/mol) managed with diet and exercise alone or with a stable dose of any oral glycaemic-lowering agent and/or incretin-based medication
Receiving a stable dose of incretin- based medications at a dose level that is sufficient for chronic weight management for at least 3 months prior to Screening and Randomisation.
Stable body weight (≤ 3% body weight change) for at least 3 months prior to Randomisation
History of at least one self-reported unsuccessful attempt to lose body weight in their lifetime

Who cannot join

Obesity primarily caused by other endocrine disorders
Type 1 diabetes mellitus
Significant hepatobiliary disease and/or any of the following results at Screening:
ALT ≥ 3.0 × ULN
AST ≥ 3.0 × ULN
TBL > 1.5 × ULN (except for cases of known Gilbert's Syndrome)
Use of insulin therapy for T2DM within 3 months prior to screening

Trial locations and contacts

96 sites in 11 countries. Contact the study team or a site near you to ask about taking part.

AstraZeneca Clinical Study Information Center contact

1-877-240-9479

information.center@astrazeneca.com

Country

City, postcode or hospital

Sites recruiting now only

96 sites in 11 countries

United States23 sites, 21 recruiting

Research Site
Beltsville, Maryland, 20705
Not yet recruiting
Research Site
Champaign, Illinois, 61822
Not yet recruiting
Research Site
Chicago, Illinois, 60640
Not yet recruiting
Research Site
Columbus, Ohio, 43215
Not yet recruiting
Research Site
Escondido, California, 92025
Not yet recruiting
Research Site
Fargo, North Dakota, 58104
Recruiting
Research Site
Franklin, Tennessee, 37067
Withdrawn
Research Site
Houston, Texas, 77043
Recruiting
Research Site
Jacksonville, Florida, 32204
Not yet recruiting
Research Site
Jacksonville, Florida, 32205
Not yet recruiting
Research Site
Kansas City, Missouri, 64111
Not yet recruiting
Research Site
Las Vegas, Nevada, 89101
Not yet recruiting
Research Site
Lincoln, California, 95648
Recruiting
Research Site
Manassas, Virginia, 20110
Not yet recruiting
Research Site
Oxon Hill, Maryland, 20745
Not yet recruiting
Research Site
Portland, Oregon, 97202
Not yet recruiting
Research Site
Renton, Washington, 98057
Withdrawn
Research Site
Smithfield, Pennsylvania, 15478
Not yet recruiting
Research Site
Somerset, New Jersey, 08873
Not yet recruiting
Research Site
Statesville, North Carolina, 28625
Recruiting
Research Site
Stockbridge, Georgia, 30281
Not yet recruiting
Research Site
Walnut Creek, California, 94598
Not yet recruiting
Research Site
Woodstock, Georgia, 30189
Recruiting

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Japan12 sites, 12 recruiting

Research Site
Chūōku, 103-0002
Not yet recruiting
Research Site
Ichinomiya-shi, 491-8558
Not yet recruiting
Research Site
Izunokuni-shi, 410-2295
Not yet recruiting
Research Site
Kamakura-shi, 247-0056
Not yet recruiting
Research Site
Kawagoe-shi, 350-0851
Not yet recruiting
Research Site
Kitakyushu-shi, 802-0077
Not yet recruiting
Research Site
Kyoto, 607-8062
Not yet recruiting
Research Site
Kyoto, 612-8555
Not yet recruiting
Research Site
Mito, 311-4153
Not yet recruiting
Research Site
Nishinomiya-shi, 662-0971
Not yet recruiting
Research Site
Ōmihachiman, 523-0082
Not yet recruiting
Research Site
Yokohama, 230-8765
Not yet recruiting

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Canada10 sites, 9 recruiting

Research Site
Calgary, Alberta, T2V 4J2
Not yet recruiting
Research Site
Calgary, Alberta, T3R 1W9
Recruiting
Research Site
Guelph, Ontario, N1H 1B1
Recruiting
Research Site
Hamilton, Ontario, L8L 5G8
Recruiting
Research Site
Joliette, Quebec, J6E 6A9
Recruiting
Research Site
Montreal, Quebec, H4J 1E3
Recruiting
Research Site
Stouffville, Ontario, L4A1H2
Recruiting
Research Site
Surrey, British Columbia, V3T 4G8
Recruiting
Research Site
Toronto, Ontario, M4G3E8
Withdrawn
Research Site
Vancouver, British Columbia, V5Y 3W2
Recruiting

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China9 sites, 9 recruiting

Research Site
Beijing, 100034
Not yet recruiting
Research Site
Changchun, 130041
Not yet recruiting
Research Site
Chengdu, 610072
Not yet recruiting
Research Site
Chengdu, 611130
Not yet recruiting
Research Site
Guangzhou, 510280
Not yet recruiting
Research Site
Huzhou, 313003
Not yet recruiting
Research Site
Nanjing, 210008
Not yet recruiting
Research Site
Nanjing, 210009
Not yet recruiting
Research Site
Ningbo, 315000
Not yet recruiting

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Denmark9 sites, 8 recruiting

Research Site
Aarhus N, 8200
Not yet recruiting
Research Site
Gandrup, 9362
Not yet recruiting
Research Site
Herlev, 2730
Not yet recruiting
Research Site
Herlev, 2730
Suspended
Research Site
Holbæk, 4300
Not yet recruiting
Research Site
Hvidovre, 2650
Not yet recruiting
Research Site
Middelfart, 5500
Not yet recruiting
Research Site
Odense, 5000
Not yet recruiting
Research Site
Vejle, 7100
Not yet recruiting

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Argentina6 sites, 6 recruiting

Research Site
Buenos Aires, C1120AAC
Not yet recruiting
Research Site
CABA, C1425HFA
Not yet recruiting
Research Site
Ciudad de Buenos Aires, C1094AAD
Recruiting
Research Site
Ramos Mejía, B1704ETD
Not yet recruiting
Research Site
Rosario, S2000PBJ
Not yet recruiting
Research Site
San Nicolás, B2900DMH
Not yet recruiting

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Brazil6 sites, 6 recruiting

Research Site
Belo Horizonte, 30150-320
Not yet recruiting
Research Site
Campinas, 13060-080
Not yet recruiting
Research Site
Campinas, 13060-803
Not yet recruiting
Research Site
São Paulo, 01236-030
Not yet recruiting
Research Site
São Paulo, 04039-002
Not yet recruiting
Research Site
São Paulo, 04266-010
Not yet recruiting

Other trials in Brazil

Israel6 sites, 6 recruiting

Research Site
Holon, 5822012
Not yet recruiting
Research Site
Jerusalem, 91120
Recruiting
Research Site
Kfar Saba, 4428164
Recruiting
Research Site
Petah Tikva, 49100
Recruiting
Research Site
Petah Tikva, 4937211
Recruiting
Research Site
Tel Aviv, 64239
Not yet recruiting

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Sweden5 sites, 4 recruiting

Research Site
Linköping, 58213
Suspended
Research Site
Lund, 222 22
Not yet recruiting
Research Site
Mölndal, 43153
Not yet recruiting
Research Site
Örebro, 703 62
Not yet recruiting
Research Site
Stockholm, 113 61
Not yet recruiting

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Turkey (Türkiye)5 sites, 5 recruiting

Research Site
Ankara, 06100
Not yet recruiting
Research Site
Ankara, 06800
Not yet recruiting
Research Site
Antalya, 07059
Not yet recruiting
Research Site
Center, 23200
Not yet recruiting
Research Site
Istanbul, 34384
Not yet recruiting

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United Kingdom5 sites, 5 recruiting

Research Site
Airdrie, ML6 0JS
Recruiting
Research Site
Chippenham, SN14 6GT
Not yet recruiting
Research Site
Hull, HU3 2PA
Recruiting
Research Site
Llandough, CF64 2XX
Recruiting
Research Site
Rotherham, S65 1DA
Not yet recruiting

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About this study

Official title: A Phase III Randomised, Double-Blind, Placebo-Controlled Multicentre Trial to Evaluate the Efficacy and Safety of AZD6234 as an Adjunct to Incretin-based Therapies in Participants With Obesity or Overweight With at Least One Weight-Related Comorbidity With or Without Type 2 Diabetes Mellitus (SELENE 3)

Read the detailed description

This is a Phase III, global, randomised, parallel-group, double-blind, multicentre study to assess the efficacy and safety of AZD6234 as an adjunct to incretin-based therapies, compared with placebo in adults with obesity or overweight with at least one weight-related comorbidity and with or without Type 2 Diabetes Mellitus (T2DM). Eligible participants will be randomised to either receive AZD6234 or matching placebo respectively. Study treatment (AZD6234 or placebo) will be added on to the participant's stable dose of background incretin-based therapies.

Conditions: Obesity or Overweight, Weight-Related Comorbidity, With/Without Diabetes Mellitus, Type 2
Being tested: Lenbelintide, Placebo
Keywords: Obesity, Overweight, AZD6234, Lenbelintide, Diabetes Mellitus, Type 2
Medical subject headings: Obesity, Overweight, Diabetes Mellitus, Type 2

What participants receive

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

LenbelintideDrug
Also called AZD6234
IMP injected subcutaneously, once a week.
PlaceboDrug
Placebo matching IMP dose injected subcutaneously, once a week.

Study groups in NCT07776509
Study group	Role	What they receive
AZD6234	Experimental	AZD6234 Receives: Drug: Lenbelintide
Placebo	Placebo comparator	Matching placebo Receives: Drug: Placebo

What is being measured

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

Percent change in body weight from baseline at 68 weeks of treatment
To evaluate the effect of AZD6234 as compared to placebo as an adjunct to incretin-based therapies in percent body weight change
Measured: 68 weeks

Secondary outcomes (8)

Percent change in body weight from baseline at 68 weeks of treatment
To evaluate the effect of AZD6234 as compared to placebo as an adjunct to incretin-based therapies in percent body weight change in the T2DM and non-T2DM sub-populations separately
Measured: 68 weeks
Absolute change in weight (kg) from baseline at 68 weeks of treatment
To evaluate the effect of AZD6234 as compared to placebo as an adjunct to incretin-based therapies on the absolute change in weight in the full population and in the T2DM and non-T2DM sub-populations separately
Measured: 68 weeks
Achievement of at least 5% body weight loss from baseline at 68 weeks of treatment
To evaluate the effect of AZD6234 as compared to placebo as an adjunct to incretin-based therapies in body weight loss of at least 5% in the full population and in the T2DM and non T2DM sub-populations separately
Measured: 68 weeks
Achievement of at least 10% body weight loss from baseline at 68 weeks of treatment
To evaluate the effect of AZD6234 as compared to placebo as an adjunct to incretin-based therapies in body weight loss of at least 10% in the full population and in the T2DM and non T2DM sub-populations separately
Measured: 68 weeks
Change in waist circumference (cm) from baseline at 68 weeks of treatment
To evaluate whether AZD6234 as an adjunct to incretin-based therapies on the waist circumference in the full population and in the T2DM and non-T2DM sub-populations separately
Measured: 68 weeks
Percent change in triglycerides from baseline at 68 weeks of treatment
To evaluate the effect of AZD6234 as compared to placebo as an adjunct to incretin-based therapies on triglycerides percent change
Measured: 68 weeks
Change in systolic blood pressure (mmHg) from baseline at 68 weeks of treatment
To evaluate the effect of AZD6234 as compared to placebo as an adjunct to incretin-based therapies on the systolic blood pressure change
Measured: 68 weeks
Change in HbA1c from baseline at 68 weeks of treatment
For participants with T2DM only: to evaluate the effect of AZD6234 as an adjunct to incretin-based therapies on HbA1c change in the T2DM sub population only
Measured: 68 weeks

Timeline

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

24 Aug 20269 Aug 2028

First posted20 Aug 2026
Study start24 Aug 2026
Primary completion9 Aug 2028 (estimated)
Study completion9 Aug 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Obesity or OverweightStudies of the same condition, open and under way.
More trials run by AstraZenecaThe 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
Model description: International, multi-centre, randomised, double-blind, placebo-controlled, parallel-group
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 500 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07776509
Sponsor's protocol ID: D8750C00011
Other IDs: 2025-523295-23-00, 159494, 2025
Acronym: SELENE 3
Status last verified: Sep 2026
First submitted: 10 Aug 2026
Last updated: 25 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Interested in taking part?

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

RecruitingPhase 1/2
A Phase 1/2a Study of WVE-007 in Adults Living With Overweight or Obesity
Overweight and Obesity
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Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System
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Study of Olatorepatide in Adult Participants Living With Overweight or Obesity Without Diabetes
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Not yet recruitingPhase 3
Efficacy And Safety of Olatorepatide in Adults With Overweight or Obesity Without Diabetes
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Recruiting
iWAIST Trial: ERCG (Endoscopic Radial Compression Gastroplasty) +Optimized Lifestyle Intervention (OLI) vs Sham + OLI for Weight Loss
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All Obesity or Overweight trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III Randomised, Double-Blind, Placebo-Controlled Multicentre Trial to Evaluate the Efficacy and Safety of AZD6234 as an Adjunct to Incretin-based Therapies in Participants With Obesity or Overweight With at Least One Weight-Related Comorbidity With or Without Type 2 Diabetes Mellitus (SELENE 3)
ClinicalTrials.gov ID: NCT07776509
Acronym / sponsor ID: SELENE 3 / D8750C00011
Conditions: Obesity or Overweight, Weight-Related Comorbidity, With/Without Diabetes Mellitus, Type 2
Keywords: Obesity, Overweight, AZD6234, Lenbelintide, Diabetes Mellitus, Type 2
Phase: Phase 3
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 500 participants (estimated)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 24 Aug 2026 (actual)
Primary completion: 9 Aug 2028 (estimated)
Study completion: 9 Aug 2028 (estimated)
First posted: 20 Aug 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: International, multi-centre, randomised, double-blind, placebo-controlled, parallel-group

Arm	Type	Receives
AZD6234	Experimental	Drug: LenbelintideAZD6234
Placebo	Placebo comparator	Drug: PlaceboMatching placebo

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Males \& females (inclusive of all gender identities) age ≥18 years
BMI ≥ 30 kg/m2 OR BMI ≥ 27 kg/m2 with at least one of the following weight-related comorbidities (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea, cardiovascular disease, heart failure, chronic kidney disease, metabolic dysfunction associated steatotic liver disease, osteoarthritis of the knee, or stress urinary incontinence
For participants with T2DM only:
Receiving a stable dose of incretin- based medications at a dose level that is sufficient for chronic weight management for at least 3 months prior to Screening and Randomisation.
Stable body weight (≤ 3% body weight change) for at least 3 months prior to Randomisation

Key exclusion criteria (7 listed)

Obesity primarily caused by other endocrine disorders
Type 1 diabetes mellitus
Significant hepatobiliary disease and/or any of the following results at Screening:
Use of insulin therapy for T2DM within 3 months prior to 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
LenbelintideAlso: AZD6234IMP injected subcutaneously, once a week.	Drug	AZD6234
PlaceboPlacebo matching IMP dose injected subcutaneously, once a week.	Drug	Placebo

Primary outcome

Percent change in body weight from baseline at 68 weeks of treatment
Time frame: 68 weeks
To evaluate the effect of AZD6234 as compared to placebo as an adjunct to incretin-based therapies in percent body weight change

8 secondary outcomes

Percent change in body weight from baseline at 68 weeks of treatment
Time frame: 68 weeks
Absolute change in weight (kg) from baseline at 68 weeks of treatment
Time frame: 68 weeks
Achievement of at least 5% body weight loss from baseline at 68 weeks of treatment
Time frame: 68 weeks
Achievement of at least 10% body weight loss from baseline at 68 weeks of treatment
Time frame: 68 weeks
Change in waist circumference (cm) from baseline at 68 weeks of treatment
Time frame: 68 weeks
Percent change in triglycerides from baseline at 68 weeks of treatment
Time frame: 68 weeks
Change in systolic blood pressure (mmHg) from baseline at 68 weeks of treatment
Time frame: 68 weeks
Change in HbA1c from baseline at 68 weeks of treatment
Time frame: 68 weeks

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 25 Sep 2026.
Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Related trials for Obesity or Overweight

RecruitingPhase 1/2
A Phase 1/2a Study of WVE-007 in Adults Living With Overweight or Obesity
Overweight and Obesity
RecruitingObservational study
Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System
Metabolic Disease, Obesity
RecruitingPhase 2
Study of Olatorepatide in Adult Participants Living With Overweight or Obesity Without Diabetes
Overweight or Obesity
Not yet recruitingPhase 3
Efficacy And Safety of Olatorepatide in Adults With Overweight or Obesity Without Diabetes
Overweight or Obesity Without Diabetes
Recruiting
iWAIST Trial: ERCG (Endoscopic Radial Compression Gastroplasty) +Optimized Lifestyle Intervention (OLI) vs Sham + OLI for Weight Loss
Overweight and/or Obesity, Metabolic Syndrome

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.

AstraZeneca Clinical Study Information Center contact

1-877-240-9479

information.center@astrazeneca.com

96 sites in 11 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lenbelintide in people with Obesity or Overweight and Weight-Related Comorbidity, run by AstraZeneca at 96 sites in 11 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 8 inclusion and 7 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 25 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 96 sites in United States, Japan, Canada, China, Denmark and 6 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?

Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent change in body weight from baseline at 68 weeks of treatment (time frame: 68 weeks). 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 NCT07776509.

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 25 Sep 2026.