HDM1002 Tablets in Chinese Overweight and Obese Adult Subjects

NCT06520540 | Not Yet Recruiting Phase 1

• 1 other identifier: HDM1002-103
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Glucagon-Like Peptide-1 Receptor Agonists

Keywords

Glucagon-Like Peptide-1 Receptor Agonists; HDM1002 tablet; Chinese overweight and obese adult

Outcome Measures

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

  Baseline, Week 12

Secondary Outcomes (12)

• change in body weight from baseline at Day 85

  Baseline, Week 12

• change in BMI from baseline at Day 85

  Baseline, Week 12

• change in waist circumference from baseline at Day 85

  Baseline, Week 12

• Plasma PK parameters

  Baseline, Week 12

• Plasma PK parameters

  Baseline, Week 12

Study Arms (4)

HDM1002 100 mg

ACTIVE COMPARATOR

Drug: HDM1002 100 mg QD 12weeks; Drug: HDM1002 200 mg QD 12weeks; Drug: HDM1002 400 mg QD 12weeks，Q 2W for titration; Drug: HDM1002 400 mg QD 12weeks，Q 3W for titration

HDM1002 200 mg

ACTIVE COMPARATOR

Drug: HDM1002 200 mg QD 12weeks; Drug: HDM1002 400 mg QD 12weeks，Q 2W for titration; Drug: HDM1002 400 mg QD 12weeks，Q 3W for titration

HDM1002 400 mg

ACTIVE COMPARATOR

Drug: HDM1002 400 mg QD 12weeks，Q 2W for titration; Drug: HDM1002 400 mg QD 12weeks，Q 3W for titration

Placebo

PLACEBO COMPARATOR

Device: Placebo

Interventions

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

HDM1002 100 mg; HDM1002 200 mg; HDM1002 400 mg

HDM1002 100 mg QD 12weeks DRUG

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

HDM1002 100 mg

HDM1002 200 mg QD 12weeks DRUG

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

HDM1002 100 mg; HDM1002 200 mg

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 100 mg; HDM1002 200 mg; HDM1002 400 mg

Placebo DEVICE

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Selection criteria:
• 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.
• Subjects meeting either of the following criteria will be excluded:
• % self-reported or documented body weight change within 3 months prior to randomization;
• Previous diagnosis of type 1, type 2 or any other type of diabetes; or using hypoglycemic drugs; or HbA1c 6.5% at screening or fasting glucose 7.0 mmol/L; or fasting glucose \<3.9 mmol / L;
• Diagnosis of overweight or obesity caused by other diseases or drugs;
• History or family history of medullary thyroid carcinoma, thyroid C cell hyperplasia, or multiple endocrine adenomatosis type 2;
• History of chronic pancreatitis or onset of acute pancreatitis within 3 months before signing an ICF;
• History of acute gallbladder disease within 3 months before signing the ICF;
• Any malignant tumor within 5 years before signing the ICF (except for basal cell carcinoma that has received curative treatment and is considered cured);
• Combination of cardiovascular and cerebrovascular diseases with obvious clinical significance, including but not limited to angina pectoris, MI, stroke or severe peripheral artery circulation disorder within 1 year before signing ICF; presence of risk factors of torsade ventricular tachycardia; presence of untreated serious arrhythmia, such as sick sinus syndrome, second or third degree atrioventricular block; or screening systolic blood pressure 160 mmHg, or diastolic blood pressure 100 mmHg;
• In the judgment of the investigator, the subjects had some diseases or conditions that may affect drug absorption, such as active inflammatory bowel disease, gastrectomy resection, any intestinal area resection, etc.;

Sponsors & Collaborators

• Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.: lead

Study Sites (1)

HDM1002

Shanghai, Shanghai Municipality, China

Location

Study Officials

• Xiaoying Li

  Zhongshan Hospital, Shanghai, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wenwen Tu

CONTACT

+86-0571-89903388; tuwenwen@eastchinapharm.com

Jing liu

CONTACT

cxyliujing@eastchinapharm.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2024
• First Posted: July 25, 2024
• Study Start: July 28, 2024
• Primary Completion: November 30, 2024
• Study Completion: December 30, 2024
• Last Updated: July 25, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)