A Study of Safety and Tolerability of Multiple Doses of HRS-7535 in Obese Subjects

NCT06621316 | Active Not Recruiting Phase 1

• 1 other identifier: HRS-7535-107
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

The study is being conducted to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple doses of HRS-7535 tablet in obese subjects.

Conditions

Overweight or Obesity

Outcome Measures

Primary Outcomes (1)

• Number of Adverse Events

  24 weeks

Secondary Outcomes (3)

• Pharmacokinetic endpoint: Concentration of HRS-7535 in plasma

  24 weeks

• Change in fasting weight at week 24

  24 weeks

• Change in waist circumference at week 24

  24 weeks

Study Arms (12)

Treatment group A

EXPERIMENTAL

HRS-7535 Tablet at dose level 1

Drug: HRS-7535 Tablet

Treatment group B

EXPERIMENTAL

HRS-7535 Tablet at dose level 2

Drug: HRS-7535 Tablet

Treatment group C

EXPERIMENTAL

HRS-7535 Tablet at dose level 3

Drug: HRS-7535 Tablet

Treatment group D

EXPERIMENTAL

HRS-7535 Tablet at dose level 4

Drug: HRS-7535 Tablet

Treatment group E

PLACEBO COMPARATOR

Placebo at dose level 1

Drug: Placebo

Treatment group F

PLACEBO COMPARATOR

Placebo at dose level 2

Drug: Placebo

Treatment group G

PLACEBO COMPARATOR

Placebo at dose level 3

Drug: Placebo

Treatment group H

PLACEBO COMPARATOR

Placebo at dose level 4

Drug: Placebo

Treatment group I

EXPERIMENTAL

HRS-7535 Tablet at dose level 1 or level 2 or level 3 or level 4.

Drug: HRS-7535 Tablet

Treatment group J

EXPERIMENTAL

HRS-7535 Tablet at dose level 1 or level 2 or level 3 or level 4.

Drug: HRS-7535 Tablet

Treatment group K

PLACEBO COMPARATOR

Placebo at dose level 1 or level 2.

Drug: Placebo

Treatment group L

PLACEBO COMPARATOR

Placebo at dose level 1 or level 2.

Drug: Placebo

Interventions

HRS-7535 Tablet DRUG

at multiple dose levels

Treatment group A; Treatment group B; Treatment group C; Treatment group D; Treatment group I; Treatment group J

Placebo DRUG

at multiple dose levels (matching active arm HRS-7535 Tablet)

Treatment group E; Treatment group F; Treatment group G; Treatment group H; Treatment group K; Treatment group L

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able and willing to provide a written informed consent.
• At screening: BMI ≥30 kg/m2.
• Have been controlled by diet and exercise for 3 months or more before screening, and the change in body weight in the past 3 months is less than 5%.
• Male and female subjects of childbearing potential through signing the informed consent form to 1 month after the last dose have no family plans and must use highly effective contraception, and female participants of childbearing potential also must have no plans to donate eggs (male participants must have no plans to be sperm donors); Female subjects of childbearing potential must have a serum pregnancy test within 7 days prior to the date of randomization, including the day of randomization.

You may not qualify if:

• Clinically significant abnormalities in relevant laboratory tests at screening.
• The results of the electrocardiogram at screening show clinically significant abnormalities that may affect the safety of the subject, including but not limited to myocardial infarction, severe arrhythmias such as supraventricular tachycardia, atrial fibrillation, atrial flutter, second- or third-degree atrioventricular block, etc.
• Heart rate or pulse \> 100 beats per minute or ECG QTcF \>450 ms at screening.
• The PHQ-9 score ≥ 15 points.
• Poor blood pressure control at screening.
• Presence or history of endocrine disease that may significantly affect body weight at screening.
• History of diabetes mellitus.
• Within 6 months prior to screening, the subject has the following diseases of clinical significance: including but not limited to neurological, psychiatric, cardiovascular, endocrine, gastrointestinal, respiratory, urinary, blood, immune system and other diseases, which may interfere with the trial results or pose additional risks to the administration of the study drug as judged by the investigator.
• Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2.
• Previous or known history of acute or chronic pancreatitis, history of cholecystitis or history of gallstones, chronic malabsorption syndrome or cholestasis.
• Severe cardiovascular and cerebrovascular diseases within 6 months prior to screening, including but not limited to: heart failure (NYHA grade II-IV), angina, stroke or transient ischemic attack, myocardial infarction, severe arrhythmia, or coronary artery bypass grafting or percutaneous coronary intervention, etc.; and/or planned revascularization of the coronary arteries, carotid arteries, or peripheral arteries at the time of screening.
• Any malignant tumor of any organ system within 5 years, regardless of whether there is evidence of local recurrence or metastasis, except for cured local cancer, such as: local basal cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the prostate.
• Those who have had serious infections, severe trauma, major and medium-sized surgeries, or planned to undergo surgery during the trial within 6 months prior to screening.
• Those with or suspected depression, bipolar disorder, suicidal tendencies, schizophrenia or other more serious mental illness; or mentally incapacitated or with a language impairment that is unable to fully understand the trial protocol or is unwilling to collaborate with study center staff.
• Presence of a history of acute or chronic hepatitis or other serious liver disease other than non-alcoholic fatty liver disease.

Sponsors & Collaborators

• Shandong Suncadia Medicine Co., Ltd.: lead

Study Sites (1)

Peking University Peoples Hospital

Beijing, Beijing Municipality, 010000, China

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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

Model Details: A multicenter, randomized, double-blind, placebo parallel-controlled Ib/II clinical trial

Study Record Dates

• First Submitted: September 29, 2024
• First Posted: October 1, 2024
• Study Start: October 30, 2024
• Primary Completion: May 30, 2025
• Study Completion: June 30, 2025
• Last Updated: April 18, 2025

Record last verified: 2025-04

Locations

CN (1)