Obesity or OverweightPhase 2ASCENDNCT06862791
A Weight Loss Study Evaluating Subcutaneous Treatment With AZD9550 and AZD6234 in Combination Against Placebo or Each of the Drugs Alone
A Phase 2 study testing AZD9550 and AZD6234 in people with Obesity or Overweight, run by AstraZeneca at 53 sites in 5 countries.
Trial summary
The purpose of this study is to determine whether treatment with AZD9550 when given in combination with AZD6234 as once weekly subcutaneous (SC) injections is superior to placebo or either agent administered as monotherapy for weight loss in participants living with obesity or overweight with at least one… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obesity or Overweight
- What is being tested?
- AZD9550 and AZD6234
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 377 participants
- Where
- 53 sitesin 5 countries
- Study dates
- 18 Feb 2025to 11 May 2026
- 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
- Participant must be 18 to 75 years of age inclusive.
- BMI: ≥ 30 kg/m2, or ≥ 27 kg/m2 with at least one weight related comorbidity.
- A stable, self-reported body weight for 3 months prior to screening.
- Male and female participants: Contraceptive use by males or females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Female participants must have a negative serum pregnancy test at screening and a negative urine pregnancy test at baseline.
- Capable of giving signed informed consent.
Who cannot join
- History of any clinically important disease or disorder, which, in the opinion of the Investigator, may put the participant at risk.
- History or presence of GI, renal, hepatic disease.
- Previous or planned bariatric surgery or fitting of a weight loss device.
- Obesity induced by endocrine disorders such as Cushing's syndrome, insulinoma or Prader-Willi syndrome.
- History of T1DM or T2DM or symptoms indicative of insulinopenia or poor glucose control.
- HbA1c ≥ 6.5% (48 mmol/mol), fasting serum glucose ≥ 126 mg/dL (7.0 mmol/L) or random glucose ≥ 200 mg/dL (11.1 mmol/L).
Show all 12Show fewer
- Significant gastric and hepatobiliary disease.
- History of acute or chronic pancreatitis or pancreatic amylase or lipase > 2 × ULN at screening.
- History of psychosis or bipolar disorder.
- History of major depressive disorder within the 2 years prior to screening or depression.
- Treatment with a GLP1 containing preparation, either as part of treatment or while participating in another clinical study within the 3 months or 5 half-lives of the drug prior to screening.
- Vulnerable populations
Trial locations and contacts
53 sites in 5 countries.
53 sites in 5 countries
United States29 sites
Research Site
Albuquerque, New Mexico, 87107
Research Site
Arlington, Virginia, 22206
Research Site
Brownsville, Texas, 78526
Research Site
Cerritos, California, 90703
Research Site
Champaign, Illinois, 61822
Research Site
Cincinnati, Ohio, 45219
Research Site
Columbus, Ohio, 43213
Research Site
Decatur, Georgia, 30030
Research Site
Dothan, Alabama, 36305
Research Site
Escondido, California, 92025
Research Site
Fargo, North Dakota, 58104
Research Site
Houston, Texas, 77043
Research Site
Huntington Park, California, 90255
Research Site
Kingsport, Tennessee, 37660
Research Site
Lincoln, California, 95648
Research Site
Medford, Oregon, 97504
Research Site
Missoula, Montana, 59804
Research Site
Omaha, Nebraska, 68114
Research Site
Palm Harbor, Florida, 34684
Research Site
Renton, Washington, 98057
Research Site
Sacramento, California, 95864
Research Site
Sioux City, Iowa, 51106
Research Site
South Bend, Indiana, 46617
Research Site
Southfield, Michigan, 48034
Research Site
Stockbridge, Georgia, 30281
Research Site
Tulsa, Oklahoma, 74133
Research Site
Valparaiso, Indiana, 46383
Research Site
Vestavia Hills, Alabama, 35216
Research Site
Waterbury, Connecticut, 06708
Canada8 sites
Research Site
Calgary, Alberta, T2V 4J2
Research Site
Guelph, Ontario, N1G 0B4
Research Site
Hamilton, Ontario, L8J 0B6
Research Site
Hamilton, Ontario, L8L 5G8
Research Site
Montreal, Quebec, H4N 2W2
Research Site
Sarnia, Ontario, N7T 4X3
Research Site
Stouffville, Ontario, L4A1H2
Research Site
Surrey, British Columbia, V3T 4G8
Germany6 sites
Research Site
Berlin, 10787
Research Site
Essen, 45136
Research Site
Falkensee, 14612
Research Site
Hamburg, 22607
Research Site
Münster, 48145
Research Site
Oldenburg, 23758
Australia5 sites
Research Site
Maroochydore, 4556
Research Site
Maroubra, 2035
Research Site
Norwood, 5067
Research Site
St Albans, 3021
Research Site
St Leonards, 2065
Japan5 sites
Research Site
Chūōku, 103-0027
Research Site
Chūōku, 104-0031
Research Site
Fukuoka, 812-0025
Research Site
Shinjuku-ku, 160-0008
Research Site
Suita-shi, 565-0853
About this study
Official title: A Phase IIb Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety and Tolerability of Co-administration of AZD9550 and AZD6234 in Participants Living With Obesity or Overweight With Co-morbidity (ASCEND)
The purpose of this study is to determine whether treatment with AZD9550 when given in combination with AZD6234 as once weekly subcutaneous (SC) injections is superior to placebo or either agent administered as monotherapy for weight loss in participants living with obesity or overweight with at least one weight-related co-morbidity.
Read the detailed description
This is a Phase IIb, global, randomised, parallel-group, double-blind, placebo-controlled, multi-centre, reduced factorial study designed to evaluate the efficacy, safety and tolerability of treatment with AZD9550 and AZD6234 in combination or as monotherapy in adults who are living with obesity or overweight with at least one of the following weight-related co-morbidities: hypertension, dyslipidemia or obstructive sleep apnoea. The study is composed of a screening period, a treatment period and a follow up period with participants expected to be in the study for approximately 47 weeks. The study will be conducted at around 60 sites and in approximately 7 countries with about, 360 participants will be randomly assigned to study intervention or placebo.
- Conditions
- Obesity or Overweight
- Being tested
- AZD9550, AZD6234, Placebo comparator
- Keywords
- Obesity, Overweight, AZD9550, AZD6234
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD9550Drug
IMP injected subcutaneous, once weekly. Unit dose strength as per CSP
AZD6234Drug
IMP injected subcutaneous, once weekly. Unit dose strength as per CSP.
Placebo comparatorDrug
Placebo matching IMP dose injected subcutaneously, once weekly.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | AZD9550 low dose + AZD6234 low dose or placebos Receives: Drug: AZD9550; Drug: AZD6234; Drug: Placebo comparator |
| Arm 2 | Experimental | AZD9550 medium dose + AZD6234 medium dose or placebos Receives: Drug: AZD9550; Drug: AZD6234; Drug: Placebo comparator |
| Arm 3 | Experimental | AZD9550 high dose + AZD6234 high dose or placebos Receives: Drug: AZD9550; Drug: AZD6234; Drug: Placebo comparator |
| Arm 4 | Experimental | AZD9550 low dose + AZD6234 medium dose or placebos Receives: Drug: AZD9550; Drug: AZD6234; Drug: Placebo comparator |
| Arm 5 | Experimental | AZD9550 medium dose + AZD6234 low dose or placebos Receives: Drug: AZD9550; Drug: AZD6234; Drug: Placebo comparator |
| Arm 6 | Experimental | AZD9550 high dose + AZD6234 medium dose or placebos Receives: Drug: AZD9550; Drug: AZD6234; Drug: Placebo comparator |
| Arm 7 | Experimental | AZD9550 medium dose + AZD6234 high dose or placebos Receives: Drug: AZD9550; Drug: AZD6234; Drug: Placebo comparator |
| Arm 8 | Experimental | AZD9550 high dose or placebo Receives: Drug: AZD9550; Drug: Placebo comparator |
| Arm 9 | Experimental | AZD6234 high dose or placebo Receives: Drug: AZD6234; Drug: Placebo comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in body weight from baseline after 36 weeks of treatment
To determine whether treatment with AZD9550 and AZD6234 in combination is superior to placebo for weight loss
Measured: 36 weeks
Weight loss ≥ 5% from baseline after 36 weeks of treatment
To assess the effect of treatment with AZD9550 and AZD6234 in combination vs placebo on the proportion of participants with weight loss ≥ 5%
Measured: 36 weeks
Secondary outcomes (8)
Absolute change in body weight from baseline after 36 weeks of treatment
To determine whether treatment with AZD9550 and AZD6234 in combination is superior to placebo for weight loss
Measured: 36 weeks
Absolute change in body weight from baseline after 36 weeks of treatment
To determine whether treatment with AZD9550 and AZD6234 in combination is superior to AZD9550 and AZD6234 monotherapy, and whether AZD9550 and AZD6234 as monotherapies are superior to placebo for weight loss
Measured: 36 weeks
Weight loss ≥ 5% from baseline after 36 weeks of treatment
To assess the effect of treatment with AZD9550 and AZD6234 in combination vs monotherapy, and assess the effect of AZD9550 and AZD6234 as monotherapies vs placebo, on the proportion of participants with weight loss ≥ 5%
Measured: 36 weeks
Weight loss ≥ 10% and ≥ 15% from baseline after 36 weeks of treatment
To assess the effect of treatment with AZD9550 and AZD6234 in combination vs placebo and monotherapy, and assess the effect of AZD9550 and AZD6234 as monotherapies vs placebo, on the proportion of participants with weight loss ≥ 10% and ≥ 15%
Measured: 36 weeks
Prevalence of ADAs to AZD9550 and AZD6234 in combination and as monotherapies after 36 weeks of treatment
To assess the immunogenicity profile of treatment with AZD9550 and AZD6234 in combination and as monotherapies
Measured: 36 weeks
Incidence of ADAs to AZD9550 and AZD6234 in combination and as monotherapies after 36 weeks of treatment
To assess immunogenicity profile of ADAs to AZD9550 and AZD6234 in combination and as monotherapies
Measured: 36 weeks
Titres of ADAs to AZD9550 and AZD6234 in combination and as monotherapies after 36 weeks of treatment
To assess the immunogenicity profile of treatment with AZD9550 and AZD6234 in combination and as monotherapies
Measured: 36 weeks
Percent change in body weight from baseline after 36 weeks of treatment
To determine whether treatment with AZD9550 and AZD6234 in combination is superior to AZD9550 and AZD6234 monotherapy, and whether AZD9550 and AZD6234 as monotherapies are superior to placebo for weight loss
Measured: 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start18 Feb 2025
- Primary completion11 May 2026
- Study completion11 May 2026
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 377 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06862791
- Sponsor's protocol ID
- D8460C00004
- Other IDs
- 2024-516176-15-00
- Acronym
- ASCEND
- Status last verified
- Jun 2026
- First submitted
- 14 Feb 2025
- Last updated
- 3 Jun 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. All request 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIb Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety and Tolerability of Co-administration of AZD9550 and AZD6234 in Participants Living With Obesity or Overweight With Co-morbidity (ASCEND)
- ClinicalTrials.gov ID
- NCT06862791
- Acronym / sponsor ID
- ASCEND / D8460C00004
- Conditions
- Obesity or Overweight
- Keywords
- Obesity, Overweight, AZD9550, AZD6234
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 377 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 18 Feb 2025 (actual)
- Primary completion
- 11 May 2026 (actual)
- Study completion
- 11 May 2026 (actual)
- First posted
- 6 Mar 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 purpose of this study is to determine whether treatment with AZD9550 when given in combination with AZD6234 as once weekly subcutaneous (SC) injections is superior to placebo or either agent administered as monotherapy for weight loss in participants living with obesity or overweight with at least one weight-related co-morbidity.
Detailed description
This is a Phase IIb, global, randomised, parallel-group, double-blind, placebo-controlled, multi-centre, reduced factorial study designed to evaluate the efficacy, safety and tolerability of treatment with AZD9550 and AZD6234 in combination or as monotherapy in adults who are living with obesity or overweight with at least one of the following weight-related co-morbidities: hypertension, dyslipidemia or obstructive sleep apnoea. The study is composed of a screening period, a treatment period and a follow up period with participants expected to be in the study for approximately 47 weeks. The study will be conducted at around 60 sites and in approximately 7 countries with about, 360 participants will be randomly assigned to study intervention or placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: AZD9550, Drug: AZD6234, Drug: Placebo comparatorAZD9550 low dose + AZD6234 low dose or placebos |
| Arm 2 | Experimental | Drug: AZD9550, Drug: AZD6234, Drug: Placebo comparatorAZD9550 medium dose + AZD6234 medium dose or placebos |
| Arm 3 | Experimental | Drug: AZD9550, Drug: AZD6234, Drug: Placebo comparatorAZD9550 high dose + AZD6234 high dose or placebos |
| Arm 4 | Experimental | Drug: AZD9550, Drug: AZD6234, Drug: Placebo comparatorAZD9550 low dose + AZD6234 medium dose or placebos |
| Arm 5 | Experimental | Drug: AZD9550, Drug: AZD6234, Drug: Placebo comparatorAZD9550 medium dose + AZD6234 low dose or placebos |
| Arm 6 | Experimental | Drug: AZD9550, Drug: AZD6234, Drug: Placebo comparatorAZD9550 high dose + AZD6234 medium dose or placebos |
| Arm 7 | Experimental | Drug: AZD9550, Drug: AZD6234, Drug: Placebo comparatorAZD9550 medium dose + AZD6234 high dose or placebos |
| Arm 8 | Experimental | Drug: AZD9550, Drug: Placebo comparatorAZD9550 high dose or placebo |
| Arm 9 | Experimental | Drug: AZD6234, Drug: Placebo comparatorAZD6234 high dose or placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participant must be 18 to 75 years of age inclusive.
- BMI: ≥ 30 kg/m2, or ≥ 27 kg/m2 with at least one weight related comorbidity.
- A stable, self-reported body weight for 3 months prior to screening.
- Male and female participants: Contraceptive use by males or females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Female participants must have a negative serum pregnancy test at screening and a negative urine pregnancy test at baseline.
Key exclusion criteria (12 listed)
- History of any clinically important disease or disorder, which, in the opinion of the Investigator, may put the participant at risk.
- History or presence of GI, renal, hepatic disease.
- Previous or planned bariatric surgery or fitting of a weight loss device.
- Obesity induced by endocrine disorders such as Cushing's syndrome, insulinoma or Prader-Willi syndrome.
- History of T1DM or T2DM or symptoms indicative of insulinopenia or poor glucose control.
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 |
|---|---|---|
| AZD9550IMP injected subcutaneous, once weekly. Unit dose strength as per CSP | Drug | Arm 1, Arm 2, Arm 3, Arm 4, Arm 5, Arm 6, Arm 7, Arm 8 |
| AZD6234IMP injected subcutaneous, once weekly. Unit dose strength as per CSP. | Drug | Arm 1, Arm 2, Arm 3, Arm 4, Arm 5, Arm 6, Arm 7, Arm 9 |
| Placebo comparatorPlacebo matching IMP dose injected subcutaneously, once weekly. | Drug | Arm 1, Arm 2, Arm 3, Arm 4, Arm 5, Arm 6, Arm 7, Arm 8, Arm 9 |
Primary outcome
Percent change in body weight from baseline after 36 weeks of treatment
Time frame: 36 weeks
To determine whether treatment with AZD9550 and AZD6234 in combination is superior to placebo for weight loss
Weight loss ≥ 5% from baseline after 36 weeks of treatment
Time frame: 36 weeks
To assess the effect of treatment with AZD9550 and AZD6234 in combination vs placebo on the proportion of participants with weight loss ≥ 5%
8 secondary outcomes
Absolute change in body weight from baseline after 36 weeks of treatment
Time frame: 36 weeks
Absolute change in body weight from baseline after 36 weeks of treatment
Time frame: 36 weeks
Weight loss ≥ 5% from baseline after 36 weeks of treatment
Time frame: 36 weeks
Weight loss ≥ 10% and ≥ 15% from baseline after 36 weeks of treatment
Time frame: 36 weeks
Prevalence of ADAs to AZD9550 and AZD6234 in combination and as monotherapies after 36 weeks of treatment
Time frame: 36 weeks
Incidence of ADAs to AZD9550 and AZD6234 in combination and as monotherapies after 36 weeks of treatment
Time frame: 36 weeks
Titres of ADAs to AZD9550 and AZD6234 in combination and as monotherapies after 36 weeks of treatment
Time frame: 36 weeks
Percent change in body weight from baseline after 36 weeks of treatment
Time frame: 36 weeks
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 3 Jun 2026.
- 20260129-draft-structured-data-ascend-sm-04-deLink provided by the sponsor.
- 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. All request 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
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 3
Efficacy, Safety and Tolerability of Switching From Glucagon-like Peptide-1 Receptor Agonists (GLP-1RA) to Maridebart Cafraglutide in Adults With Obesity or Overweight (MARITIME-SWITCH)
Obesity or Overweight
RecruitingPhase 1
A Study to Learn How Different Forms of the Study Medicine Called Berobenatide is Taken up Into the Blood in Adults With Overweight or Obesity
Overweight and/or Obesity, Healthy Participants
RecruitingPhase 2
Study of Olatorepatide in Adult Participants Living With Overweight or Obesity Without Diabetes
Overweight or Obesity
Active, not recruitingPhase 3
AMAZE 2: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Type 2 Diabetes Lose Weight
Diabetes Mellitus, Overweight
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.
The record lists no contact. Use the official record to reach the sponsor.
53 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AZD9550 and AZD6234 in people with Obesity or Overweight, run by AstraZeneca at 53 sites in 5 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 12 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 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 53 sites in United States, Canada, Germany, 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. 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?
Percent change in body weight from baseline after 36 weeks of treatment (time frame: 36 weeks). 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 3 Jun 2026.