Clinical trial NCT06988553: A Phase Ib Study of AZD5004 in Chinese Participants With Overweight/Obesity With or Without Type 2 Diabetes Mellitus
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Obesity or Overweight
Type 2 Diabetes
Lead sponsor: Eccogene
Sponsor class: INDUSTRY
First posted: 2025-05-25
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
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)
timeFrame: From baseline to week 16.
Secondary outcomes:
measure: AZD5004 concentrations in plasma
timeFrame: Week 16.
measure: Area under the concentration-time curve over a dosing interval (AUCtau)
timeFrame: Week 16.
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: Week 16.
measure: Half-Life (t1/2)
timeFrame: Week 16.
measure: Time of Occurrence of Maximum Plasma Concentration (tmax)
timeFrame: Week 16.
measure: Trough concentration (Ctrough)
timeFrame: Week 16.
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
city: Ha'erbin
country: China
facility: The Fourth Affiliated Hospital of Harbin Medical University
city: Hefei
country: China
facility: The Second People's Hospital of Hefei
city: Jinan
country: China
facility: Jinan Central Hospital
city: Shanghai
country: China
facility: Shanghai Pudong New District People's Hospital
city: Tianjin
country: China
facility: General Hospital of Tianjin Medical University
Study officials:
affiliation: Eccogene Clinical Trials
name: Eccogene
role: STUDY_DIRECTOR
References: