CompletedPhase 1

A Phase Ib Study of AZD5004 in Chinese Participants With Overweight/Obesity With or Without Type 2 Diabetes Mellitus

China45 participantsStarted 2025-06-17

Plain-language summary

The purpose of this study is to evaluate the safety, tolerability, and PK of AZD5004 compared with placebo in Chinese participants with overweight/obesity with or without T2DM.

Who can participate

Age range

18 Years – 74 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Aged 18 to 74 years inclusive at the time of signing the informed consent. * Stable self-reported body weight for 3 months prior to Screening. Inclusion Criteria for Cohort A: \- 27 kg/m2 ≤ BMI ≤ 35 kg/m2 and weigh at least 60 kg at Screening. Inclusion Criteria for Cohort B: * Diagnosed with T2DM for at least 6 months prior to signing the informed consent. * HbA1c value at Screening of ≥ 7.0% and ≤ 10.5% * BMI of ≥ 24 kg/m2 at the Screening Visit. Exclusion Criteria: * History of, or any existing condition that influence the participant's ability to participate or affect the interpretation of the results of the study. * Known clinically significant gastric emptying abnormality. * Significant hepatic disease. * Abnormal renal function. * History of acute pancreatitis and chronic pancreatitis, gallstones. * Uncontrolled thyroid disease.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of participants with adverse events (AEs), serious adverse events (SAEs), adverse event leading to the discontinuation of study intervention (DAEs), death, and Adverse events of special interest (AESIs)

Timeframe: From baseline to week 16.

Trial details

NCT IDNCT06988553

SponsorEccogene

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-11-28

View on ClinicalTrials.gov More Obesity or Overweight trials

Who can participate

Age range

18 Years – 74 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.