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Obesity/OverweightPhase 2NCT07017179

This is a Multi-centre, Multi-drug, Platform Study in Chinese Participants Living With Obesity / Overweight

A Phase 2 study testing AZD6234, AZD9550 and Plocebo in people with Obesity/Overweight, run by AstraZeneca at 3 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This study is to assess the safety and tolerability, PK characterisation, efficacy, and immunogenicity of the study intervention, and it allows assessment of the monotherapy or combination therapy of AZD6234 and AZD9550 in different sub-studies. Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Obesity/Overweight
What is being tested?
AZD6234, AZD9550 and Plocebo
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
16 participants
Where
3 sitesChina
Study dates
20 May 2025to 23 Oct 2026
Phase
Phase 2
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 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Age 18 to 55 years.
  • BMI ≥ 27 kg/m2.
  • Stable body weight for 3 months prior to screening.
  • Male and female (Contraceptive use by participants or participant partners should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies).
  • Participants should refrain from blodd donation throughout the sub-study, including the follow-up period.
  • Negative pregnancy test at screening and randomisation for FOCBP and must not be breastfeeding.

Who cannot join

  • Have received prescription medication or non-prescription medication for weight loss within the last 3 months prior to screening.
  • History of type 1 or type 2 diabetes mellitus or symptoms indicative of insulinopenia or poor glucose control.
  • Treatment with diabetes medication in past 3 months prior to screening.
  • HbA1c ≥ 6.5% (48 mmol/mol) at screening.
  • Gastroparesis (or similar) requiring treatment.
  • Significant inflammatory bowel disease or other severe disease or surgery affecting the upper GI tract.
Show all 23Show fewer
  • Significant hepatic disease (except for non-alcoholic steatohepatitis or non-alcoholic fatty liver disease without portal hypertension or cirrhosis) and/or participants with any of the following results at screening:
  • AST ≥ 2.5 × ULN
  • ALT ≥ 2.5 × ULN
  • TBL ≥ 1.5 × ULN.
  • Prior history of cholecystectomy or untreated cholelithiasis.
  • History of acute or chronic pancreatitis or pancreatic amylase or lipase > 2 × ULN at screening.
  • Severely uncontrolled hypertension defined as systolic BP ≥ 160 mmHg and/or diastolic BP ≥ 100 mmHg on the average of 2 seated measurements after being at rest for at least 5 minutes.
  • HR < 50 bpm or > 100 bpm after being at rest for 5 minutes.
  • Impaired renal function defined as eGFR ≤ 45 mL/minute/1.73 m2 at screening (GFR estimated according to CKD-EPI).
  • History of psychosis or bipolar disorder.
  • Severe vitamin D deficiency defined as a 25-OH vitamin D level < 12 ng/mL.
  • Uncontrolled thyroid disease, defined as TSH > ULN or < LLN for the laboratory reference range, as judged by the PI at screening.
  • Sub-study 2 only
  • Personal or family history (first-degree relative) of MTC or MEN2.
  • History of marijuana or THC use within 3 months before screening, or unwilling/unable to abstain from marijuana or THC use during the study.
  • Previous hospitalisation for any psychiatric reason.
  • PHQ-9 score ≥ 15 within the 2 years prior to screening or at screening.

Trial locations and contacts

3 sites in 1 country.

China3 sites

  • Research Site

    Jinan, 250001

  • Research Site

    Nanjing, 210011

  • Research Site

    Shanghai, 200032

Other trials in China

About this study

Official title: A Phase IIa Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of AZD6234, AZD9550, and AZD6234 in Combination With AZD9550 in Chinese Participants Living With Obesity/Overweight

This study is to assess the safety and tolerability, PK characterisation, efficacy, and immunogenicity of the study intervention, and it allows assessment of the monotherapy or combination therapy of AZD6234 and AZD9550 in different sub-studies.

Read the detailed description

This is a Phase Ⅱa, multi-centre, multi-drug, platform study in Chinese participants living with obesity/overweight. This platform study will consist of several sub-studies. Eligible participants will be allocated to one sub-study to receive the study intervention(s). Each sub-study will consist of a screening period, a treatment period, and a follow-up period.

Sub-study 1: AZD6234 Monotherapy This study will explore the safety, tolerability, pharmacokinetic (PK), efficacy, and immunogenicity of AZD6234 in Chinese participants with obesity/overweight, approximate 18 participants will be randomised in sub-study 1. The sub-study will comprise 3 periods totalling up to approximately 23 weeks.

Sub-study 2: AZD9550 Monotherapy and AZD6234 in combination with AZD9550 This study will explore the safety, tolerability, PK, efficacy, and immunogenicity of AZD9550 and of AZD6234 in combination with AZD9550 in Chinese participants with obesity/overweight, approximately 30 participants will be randomised in sub-study 2 (15 in Cohort A and 15 in Cohort B). The sub-study will comprise 3 periods totalling up to approximately 35 weeks.

Being tested
AZD6234, Placebo, AZD9550, Plocebo, AZD6234 in combination with AZD9550
Keywords
Obesity, Overweight, Chinese Participants, AZD6234, AZD9550
Medical subject headings
Obesity, Overweight

What participants receive

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

  • AZD6234Drug

    Participants will receive a subcutaneous injection weekly

  • PlaceboDrug

    Participants will receive a subcutaneous injection weekly.

  • AZD9550Drug

    Participants will receive a subcutaneous injection weekly

  • PloceboDrug

    Participants will receive a subcutaneous injection weekly

  • AZD6234 in combination with AZD9550Drug

    Participants will receive a subcutaneous injection weekly

  • PlaceboDrug

    Participants will receive a subcutaneous injection weekly

Study groups in NCT07017179
Study groupRoleWhat they receive
AZD6234 (sub-study 1)ExperimentalParticipants will receive subcutaneous injection of AZD6234 on Day 1 and continue for 16 weeks.
Receives: Drug: AZD6234
Placebo (sub-study 1)Placebo comparatorParticipants will receive subcutaneous injection of matched volume of placebo on Day 1 and continue for 16 weeks.
Receives: Drug: Placebo
AZD9550（sub-study 2 Cohort A)ExperimentalParticipants will receive subcutaneous injection of AZD9550 on Day 1 and continue for 28 weeks.
Receives: Drug: AZD9550
Placebo (sub-study 2 Cohort A)Placebo comparatorParticipants will receive subcutaneous injection of matched volume of placebo on Day 1 and continue for 28 weeks.
Receives: Drug: Plocebo
AZD6234 in combination with AZD9550 (sub-study 2 Cohort B)ExperimentalParticipants will receive subcutaneous injection of AZD6234 and AZD9550 on Day 1 and continue for 28 weeks.
Receives: Drug: AZD6234 in combination with AZD9550
Placebo (sub-study 2 Cohort B)Placebo comparatorParticipants will receive subcutaneous injection of matched volume of placebo on Day 1 and continue for 28 weeks.
Receives: Drug: Placebo

What is being measured

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

  1. Numbers of participant with Adverse Events (AEs) and Serious adverse events (SAEs) (sub-study 1).

    To assess the safety and tolerability of repeated subcutaneous(SC) doses of AZD6234 compared to placebo.

    Measured: From baseline to Day 141

  2. Numbers of participant with Adverse Events (AEs) and Serious adverse events (SAEs) (sub-study 2).

    To assess the safety and tolerability of repeated SC doses of AZD9550 and AZD6234 in combination with AZD9550 compared to placebo.

    Measured: From baseline to Day 225

Secondary outcomes (18)

  1. PK parameters : Cmax (sub-study 1)

    To characterise the PK of AZD6234 following repeated subcutaneous (SC) doses.

    Measured: Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 85,106,113,120,127,141 Pre-dose. Day 1,36,43,57,106 post-dose 2,4,8,12,24,36,48,60,72,96 hours.

  2. PK parameters : Tmax (sub-study 1)

    To characterise the PK of AZD6234 following repeated SC doses.

    Measured: Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 85,106,113,120,127,141 Pre-dose. Day 1,36,43,57,106 post-dose 2,4,8,12,24,36,48,60,72,96 hours.

  3. PK parameters : AUClast (sub-study 1)

    To characterise the PK of AZD6234 following repeated SC doses.

    Measured: Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 85,106,113,120,127,141 Pre-dose. Day 1,36,43,57,106 post-dose 2,4,8,12,24,36,48,60,72,96 hours.

  4. PK parameters : AUCtau (sub-study 1)

    To characterise the PK of AZD6234 following repeated SC doses.

    Measured: Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 85,106,113,120,127,141 Pre-dose. Day 1,36,43,57,106 post-dose 2,4,8,12,24,36,48,60,72,96 hours.

  5. Percent change in body weight from baseline to Week 16 (sub-study 1)

    To assess the effects of AZD6234 on the body weight change from baseline with and without placebo correction.

    Measured: From baseline to Week 16

  6. Incidence of ADA to AZD6234 (sub-study 1).

    To evaluate the immunogenicity of AZD6234 following repeated SC doses.

    Measured: Day 1 to Day 141

  7. ADA titer of AZD6234 (sub-study 1).

    To evaluate the immunogenicity of AZD6234 following repeated SC doses.

    Measured: Day 1 to Day 141

  8. PK parameters : Cmax (sub-study 2 Cohort A)

    To characterise the PK of AZD9550 following repeated SC doses.

    Measured: Days 1, 15, 29, 57, 85, 113, 141, 190, 204, 211, 225 per dose. Days 1, 57, 113, 141,190 post-dose 6, 12, 18, 24 hours (± 10 minutes). Day 190 post-dos 30, 36, 42, 48, 54, 60, 72, 96, 120, 144,168 hours (± 30 minutes).

  9. PK parameters : Tmax (sub-study 2 Cohort A)

    To characterise the PK of AZD9550 following repeated SC doses.

    Measured: Days 1, 15, 29, 57, 85, 113, 141, 190, 204, 211, 225 per dose. Days 1, 57, 113, 141,190 post-dose 6, 12, 18, 24 hours (± 10 minutes). Day 190 post-dos 30, 36, 42, 48, 54, 60, 72, 96, 120, 144,168 hours (± 30 minutes).

  10. PK parameters : AUClast (sub-study 2 Cohort A)

    To characterise the PK of AZD9550 following repeated SC doses.

    Measured: Days 1, 15, 29, 57, 85, 113, 141, 190, 204, 211, 225 per dose. Days 1, 57, 113, 141,190 post-dose 6, 12, 18, 24 hours (± 10 minutes). Day 190 post-dos 30, 36, 42, 48, 54, 60, 72, 96, 120, 144,168 hours (± 30 minutes).

  11. PK parameters : AUCtau (sub-study 2 Cohort A)

    To characterise the PK of AZD9550 following repeated SC doses.

    Measured: Days 1, 15, 29, 57, 85, 113, 141, 190, 204, 211, 225 per dose. Days 1, 57, 113, 141,190 post-dose 6, 12, 18, 24 hours (± 10 minutes). Day 190 post-dos 30, 36, 42, 48, 54, 60, 72, 96, 120, 144,168 hours (± 30 minutes).

  12. Plasma trough concentration (sub-study 2 Cohort B).

    To characterise the PK of AZD9550 and AZD6234 following repeated SC doses

    Measured: Day 1 to Day 225

  13. Percent change in body weight from baseline to Week 28 (sub-study 2 ), placebo as comparator

    To assess the effects of AZD9550 and AZD6234 in combination with AZD9550 on the body weight change from baseline with and without placebo correction.

    Measured: From baseline to Week 28

  14. Percent change in body weight from baseline to Week 28 (sub-study 2, AZD9550 as comparator)

    To assess the effects of AZD6234 in combination with AZD9550 compared to AZD9550 on the body weight change from baseline.

    Measured: From baseline to Week 28

  15. Incidence of ADA to AZD9550 (sub-study 2).

    To evaluate the immunogenicity of AZD9550 following repeated SC doses.

    Measured: Day 1 to Day 225

  16. ADA titer of AZD9550 (sub-study 2 Cohort A).

    To evaluate the immunogenicity of AZD9550 following repeated SC doses.

    Measured: Day 1 to Day 225

  17. Incidence of ADA to AZD6234 and AZD9550 combination therapy (sub-study 2 Cohort B).

    To evaluate the immunogenicity of AZD6234 and AZD9550 following repeated SC combination therapy doses.

    Measured: Day 1 to Day 225

  18. ADA titer of AZD6234 and AZD9550 combination therapy (sub-study 2 Cohort B).

    To evaluate the immunogenicity of AZD6234 and AZD9550 following repeated SC combination therapy doses.

    Measured: Day 1 to Day 225

Timeline

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

  1. First posted12 Jun 2025
  2. Study start20 May 2025
  3. Primary completion23 Oct 2026 (estimated)
  4. Study completion23 Oct 2026 (estimated)

Resources

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
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07017179
Sponsor's protocol ID
D8750C00009
Status last verified
Sep 2026
First submitted
14 May 2025
Last updated
29 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AZD6234, AZD9550 and Plocebo in people with Obesity/Overweight, run by AstraZeneca at 3 sites in China.

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 23 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 29 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 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

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?

Numbers of participant with Adverse Events (AEs) and Serious adverse events (SAEs) (sub-study 1). (time frame: From baseline to Day 141). 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?

On the ClinicalTrials.gov record for NCT07017179.

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 29 Sep 2026.

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