Health TrialsbyHealthPanel

HDM1002 Tablets in Chinese Overweight and Obese Adult Subjects

ConditionGlucagon-Like Peptide-1 Receptor Agonists
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-60
SponsorHangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

About this trial

• To assess the safety of multiple oral doses of HDM1002 tablets under different titrations in Chinese overweight and obese adult subjects.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Chinese subjects aged 18 to 60 years (including 18 years and 60 years old), either male or female subjects;

BMI at 24.0 to 36.0 kg at screening and at random / m2Between (including 24.0 and 36.0 kg / m2）；

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);

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.

Disqualifiers

Chinese subjects aged 18 to 60 years (including 18 years and 60 years old), either male or female subjects;

BMI at 24.0 to 36.0 kg at screening and at random / m2Between (including 24.0 and 36.0 kg / m2）；

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);

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • HDM1002 100 mg QD 12weeks

    Drug

    Participants received maintenance dose of 100 mg HDM1002 administered orally once daily (QD)

  • HDM1002 200 mg QD 12weeks

    Drug

    Participants received maintenance dose of 200 mg HDM1002 administered orally once daily (QD)

  • HDM1002 400 mg QD 12weeks，Q 2W for titration

    Drug

    Participants received maintenance dose of 400 mg HDM1002 administered orally once daily (QD) Q 2W for titration

  • HDM1002 400 mg QD 12weeks，Q 3W for titration

    Drug

    Participants received maintenance dose of 400 mg HDM1002 administered orally once daily (QD) Q 3W for titration

  • Placebo

    Device

    Placebo

Treatment groups

72 Participants
are divided into 4 treatment groups
Group A: HDM1002 100 mgActive comparator 4 interventions
Group B: HDM1002 200 mgActive comparator 3 interventions
Group C: HDM1002 400 mgActive comparator 2 interventions
Group D: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

TEAEs, SAEs, AEs leading to withdrawal, and AEs leading to death, AEs of special interest

TEAEs and SAEs (incidence, severity and causal relationship), AEs leading to withdrawal, and AEs leading to death, AEs of special interest

Time frame
Baseline, Week 12

Secondary outcomes

1

change in body weight from baseline at Day 85

Weight during treatment from baseline

Time frame
Baseline, Week 12
2

change in BMI from baseline at Day 85

change in body mass index (BMI) from baseline

Time frame
Baseline, Week 12
3

change in waist circumference from baseline at Day 85

Change in waist circumference from baseline

Time frame
Baseline, Week 12
4

Plasma PK parameters

Cmax

Time frame
Baseline, Week 12

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: