Obesity or OverweightPhase 1NCT06988553
A Phase Ib Study of AZD5004 in Chinese Participants With Overweight/Obesity With or Without Type 2 Diabetes Mellitus
A Phase 1 study testing AZD5004 in people with Obesity or Overweight and Type 2 Diabetes, run by Eccogene at 6 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Obesity or Overweight, Type 2 Diabetes
- What is being tested?
- AZD5004
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 6 sitesChina
- Study dates
- 17 Jun 2025to 28 Nov 2025
- Phase
- Phase 1
- 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 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 27 kg/m2 ≤ BMI ≤ 35 kg/m2 and weigh at least 60 kg at Screening.
- 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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
The Fourth Affiliated Hospital of Harbin Medical University
Ha’erbin
The Second People's Hospital of Hefei
Hefei
Jinan Central Hospital
Jinan
Shanghai Pudong New District People's Hospital
Shanghai
General Hospital of Tianjin Medical University
Tianjin
About this study
Official title: A Phase Ib, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of AZD5004 in Chinese Participants With Overweight/Obesity With or Without Type 2 Diabetes Mellitus
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.
Read the detailed description
This is a Phase Ib, randomized, parallel-group, double-blind, placebo-controlled, multicentre, 2-arm treatment study to investigate the safety, tolerability, and PK of AZD5004 compared with placebo in Chinese male and female participants aged 18 to 74 years, who are overweight/obese with or without T2DM. The primary endpoints are incidence of AEs, SAEs, DAEs, death, AESIs, laboratory parameters, 12-lead ECG, and vital signs.
- Conditions
- Obesity or Overweight, Type 2 Diabetes
- Being tested
- AZD5004, Placebo
- 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.
AZD5004Drug
AZD5004 will be administered as an oral tablet once daily.
PlaceboDrug
Placebo will be administered as an oral tablet once daily.
| Study group | Role | What they receive |
|---|---|---|
| AZD5004 | Experimental | Participants will receive AZD5004 orally. Receives: Drug: AZD5004 |
| Placebo | Placebo comparator | Participants will receive Placebo orally. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
To evaluate the safety and tolerability of AZD5004 compared with placebo.
Measured: From baseline to week 16.
Secondary outcomes (6)
AZD5004 concentrations in plasma
To characterize the PK profile of AZD5004 following repeated administration.
Measured: Week 16.
Area under the concentration-time curve over a dosing interval (AUCtau)
To characterize the PK profile of AZD5004 following repeated administration.
Measured: Week 16.
Maximum Observed Plasma Concentration (Cmax)
To characterize the PK profile of AZD5004 following repeated administration.
Measured: Week 16.
Half-Life (t1/2)
To characterize the PK profile of AZD5004 following repeated administration.
Measured: Week 16.
Time of Occurrence of Maximum Plasma Concentration (tmax)
To characterize the PK profile of AZD5004 following repeated administration.
Measured: Week 16.
Trough concentration (Ctrough)
To characterize the PK profile of AZD5004 following repeated administration.
Measured: Week 16.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start17 Jun 2025
- Primary completion28 Nov 2025
- Study completion28 Nov 2025
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.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eccogene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eccogene, Study director, Eccogene Clinical Trials
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06988553
- Sponsor's protocol ID
- D7260C00005
- Status last verified
- Aug 2025
- First submitted
- 16 May 2025
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of AZD5004 in Chinese Participants With Overweight/Obesity With or Without Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT06988553
- Acronym / sponsor ID
- D7260C00005
- Conditions
- Obesity or Overweight, Type 2 Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- EccogeneIndustry (pharma, biotech, devices)
- Study start
- 17 Jun 2025 (actual)
- Primary completion
- 28 Nov 2025 (actual)
- Study completion
- 28 Nov 2025 (actual)
- First posted
- 25 May 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 evaluate the safety, tolerability, and PK of AZD5004 compared with placebo in Chinese participants with overweight/obesity with or without T2DM.
Detailed description
This is a Phase Ib, randomized, parallel-group, double-blind, placebo-controlled, multicentre, 2-arm treatment study to investigate the safety, tolerability, and PK of AZD5004 compared with placebo in Chinese male and female participants aged 18 to 74 years, who are overweight/obese with or without T2DM. The primary endpoints are incidence of AEs, SAEs, DAEs, death, AESIs, laboratory parameters, 12-lead ECG, and vital signs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AZD5004 | Experimental | Drug: AZD5004Participants will receive AZD5004 orally. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive Placebo orally. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
- 27 kg/m2 ≤ BMI ≤ 35 kg/m2 and weigh at least 60 kg at Screening.
- Diagnosed with T2DM for at least 6 months prior to signing the informed consent.
- HbA1c value at Screening of ≥ 7.0% and ≤ 10.5%
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| AZD5004AZD5004 will be administered as an oral tablet once daily. | Drug | AZD5004 |
| PlaceboPlacebo will be administered as an oral tablet once daily. | Drug | Placebo |
Primary outcome
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)
Time frame: From baseline to week 16.
To evaluate the safety and tolerability of AZD5004 compared with placebo.
6 secondary outcomes
AZD5004 concentrations in plasma
Time frame: Week 16.
Area under the concentration-time curve over a dosing interval (AUCtau)
Time frame: Week 16.
Maximum Observed Plasma Concentration (Cmax)
Time frame: Week 16.
Half-Life (t1/2)
Time frame: Week 16.
Time of Occurrence of Maximum Plasma Concentration (tmax)
Time frame: Week 16.
Trough concentration (Ctrough)
Time frame: Week 16.
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 23 Dec 2025.
- Individual participant dataSharing planned: No
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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.
Eccogene study director
Eccogene Clinical Trials
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AZD5004 in people with Obesity or Overweight and Type 2 Diabetes, run by Eccogene at 6 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 6 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 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
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) (time frame: From baseline to week 16.). 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 23 Dec 2025.