NCT07017179

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
871

participants targeted

Target at P75+ for phase_2

Timeline
3mo left

Started May 2025

Shorter than P25 for phase_2

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress80%
May 2025Aug 2026

First Submitted

Initial submission to the registry

May 14, 2025

Completed
6 days until next milestone

Study Start

First participant enrolled

May 20, 2025

Completed
23 days until next milestone

First Posted

Study publicly available on registry

June 12, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 6, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 6, 2026

Last Updated

April 20, 2026

Status Verified

April 1, 2026

Enrollment Period

1.2 years

First QC Date

May 14, 2025

Last Update Submit

April 17, 2026

Conditions

Obesity/Overweight

Keywords

ObesityOverweightChinese ParticipantsAZD6234AZD9550

Outcome Measures

Primary Outcomes (2)

  • 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.

    From baseline to Day 141

  • 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.

    From baseline to Day 225

Secondary Outcomes (18)

  • PK parameters : Cmax (sub-study 1)

    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.

  • PK parameters : Tmax (sub-study 1)

    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.

  • PK parameters : AUClast (sub-study 1)

    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.

  • PK parameters : AUCtau (sub-study 1)

    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.

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

    From baseline to Week 16

  • +13 more secondary outcomes

Study Arms (6)

AZD6234 (sub-study 1)

EXPERIMENTAL

Participants will receive subcutaneous injection of AZD6234 on Day 1 and continue for 16 weeks.

Drug: AZD6234

Placebo (sub-study 1)

PLACEBO COMPARATOR

Participants will receive subcutaneous injection of matched volume of placebo on Day 1 and continue for 16 weeks.

Drug: Placebo

AZD9550（sub-study 2 Cohort A)

EXPERIMENTAL

Participants will receive subcutaneous injection of AZD9550 on Day 1 and continue for 28 weeks.

Drug: AZD9550

Placebo (sub-study 2 Cohort A)

PLACEBO COMPARATOR

Participants will receive subcutaneous injection of matched volume of placebo on Day 1 and continue for 28 weeks.

Drug: Plocebo

AZD6234 in combination with AZD9550 (sub-study 2 Cohort B)

EXPERIMENTAL

Participants will receive subcutaneous injection of AZD6234 and AZD9550 on Day 1 and continue for 28 weeks.

Drug: AZD6234 in combination with AZD9550

Placebo (sub-study 2 Cohort B)

PLACEBO COMPARATOR

Participants will receive subcutaneous injection of matched volume of placebo on Day 1 and continue for 28 weeks.

Drug: Placebo

Interventions

AZD6234DRUG

Participants will receive a subcutaneous injection weekly

AZD6234 (sub-study 1)
PlaceboDRUG

Participants will receive a subcutaneous injection weekly.

Placebo (sub-study 1)
AZD9550DRUG

Participants will receive a subcutaneous injection weekly

AZD9550（sub-study 2 Cohort A)
PloceboDRUG

Participants will receive a subcutaneous injection weekly

Placebo (sub-study 2 Cohort A)
AZD6234 in combination with AZD9550DRUG

Participants will receive a subcutaneous injection weekly

AZD6234 in combination with AZD9550 (sub-study 2 Cohort B)

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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).
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Research Site

Jinan, 250001, China

ACTIVE NOT RECRUITING

Research Site

Nanjing, 210011, China

RECRUITING

Research Site

Shanghai, 200032, China

RECRUITING

MeSH Terms

Conditions

ObesityOverweight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479information.center@astrazeneca.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2025

First Posted

June 12, 2025

Study Start

May 20, 2025

Primary Completion (Estimated)

August 6, 2026

Study Completion (Estimated)

August 6, 2026

Last Updated

April 20, 2026

Record last verified: 2026-04

Locations

CN(3)