Glucagon-Like Peptide-1 Receptor Agonists
Conditions
Keywords
Glucagon-Like Peptide-1 Receptor Agonists, HDM1002 tablet, Chinese overweight and obese adult
Brief summary
• To assess the safety of multiple oral doses of HDM1002 tablets under different titrations in Chinese overweight and obese adult subjects.
Interventions
DRUGHDM1002 100 mg QD 12weeks
Participants received maintenance dose of 100 mg HDM1002 administered orally once daily (QD)
Participants received maintenance dose of 200 mg HDM1002 administered orally once daily (QD)
DRUGHDM1002 400 mg QD 12weeks，Q 2W for titration
Participants received maintenance dose of 400 mg HDM1002 administered orally once daily (QD) Q 2W for titration
DRUGHDM1002 400 mg QD 12weeks，Q 3W for titration
Participants received maintenance dose of 400 mg HDM1002 administered orally once daily (QD) Q 3W for titration
DEVICEPlacebo
Placebo
Sponsors
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
1. Chinese subjects aged 18 to 60 years (including 18 years and 60 years old), either male or female subjects; 2. BMI at 24.0 to 36.0 kg at screening and at random / m2Between (including 24.0 and 36.0 kg / m2）； 3. For fertile subjects, female subjects from 14 days before the informed consent form (ICF) to 30 days after the last administration, male subjects within 90 days after the ICF to the last administration, without birth planning and agreed to highly effective contraception (see Section 5.2.3 for details); 4. Ability to understand the procedures and methods of this study, voluntarily sign the ICF, and be willing to strictly comply with the clinical trial protocol requirements to complete the relevant process.
Exclusion criteria
Selection criteria: Subjects must meet all of the following inclusion criteria to be enrolled in this study: 1. Chinese subjects aged 18 to 60 years (including 18 years and 60 years old), either male or female subjects; 2. BMI at 24.0 to 36.0 kg at screening and at random / m2Between (including 24.0 and 36.0 kg / m2）； 3. For fertile subjects, female subjects from 14 days before the informed consent form (ICF) to 30 days after the last administration, male subjects within 90 days after the ICF to the last administration, without birth planning and agreed to highly effective contraception (see Section 5.2.3 for details); 4. Ability to understand the procedures and methods of this study, voluntarily sign the ICF, and be willing to strictly comply with the clinical trial protocol requirements to complete the relevant process.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| TEAEs, SAEs, AEs leading to withdrawal, and AEs leading to death, AEs of special interest | Baseline, Week 12 | TEAEs and SAEs (incidence, severity and causal relationship), AEs leading to withdrawal, and AEs leading to death, AEs of special interest |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in body weight from baseline at Day 85 | Baseline, Week 12 | Weight during treatment from baseline |
| change in BMI from baseline at Day 85 | Baseline, Week 12 | change in body mass index (BMI) from baseline |
| change in waist circumference from baseline at Day 85 | Baseline, Week 12 | Change in waist circumference from baseline |
| Plasma PK parameters | Baseline, Week 12 | Cmax |
Countries
China
Contacts
Primary ContactWenwen Tu
Backup ContactJing liu
Outcome results
None listed