HRS9531 Tablet / HRS9531 Tablet Placebo / Chronic Management of Body Weight · Phase 3 Trial

A Clinical Study to Evaluate the Efficacy and Safety of HRS9531 Tablets in Overweight or Obese Subjects

ClinicalTrials.gov · August 13, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a Phase 3 placebo-controlled trial of HRS9531 for chronic weight management in overweight or obese subjects, currently recruiting with no results posted. No efficacy or safety data are available from this registry record, and conclusions cannot be drawn until outcome data are reported.

What was studied

Phase 3, Interventional, Randomized, Parallel, Quadruple masking, Treatment purpose. Chronic Management of Body Weight; age from 18 Years; to 75 Years. Intervention: HRS9531 Tablet Group. Compared with: HRS9531 Tablet Placebo Group — Placebo Comparator. n = 675. 2 sites: China.

Key findings

Safety

No efficacy, safety, or adverse event data are reported

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a registry record of a Phase 3 RCT currently recruiting, with no posted results; the study design is sound but evidence cannot be assessed until outcomes are reported.

Study design

As stated by the source record.

MethodsPrimary outcome measures: Percentage change from baseline in body weight after 52 weeks of treatment (assessed at After 52 weeks of treatment.); Proportion of subjects with weight loss of ≥ 5% from baseline in body weight after 52 weeks of treatment (assessed at After 52 weeks of treatment.)

DesignPhase 3, Interventional, Randomized, Parallel, Quadruple masking, Treatment purpose

PopulationChronic Management of Body Weight; age from 18 Years; to 75 Years

Sample size675

InterventionHRS9531 Tablet Group

ComparatorHRS9531 Tablet Placebo Group — Placebo Comparator

Setting2 sites: China

Reported figures

Quoted from the source exactly as published.

PhasePHASE 3

Planned enrollment675

Treatment duration52 weeks

Primary endpoint 1Percentage change from baseline in body weight after 52 weeks

Primary endpoint 2Proportion of subjects with weight loss of ≥5% from baseline after 52 weeks

Caveats

This is a registry record only; no results have been posted or published
Study status is RECRUITING; enrollment and follow-up are ongoing
No efficacy, safety, or adverse event data are reported
Key methodological details (randomisation method, blinding approach, analysis plan) are not provided in this registry excerpt

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

strong

Phase 3, randomized, placebo-controlled, interventional trial design

Directness

strong

Primary endpoints are body weight change and ≥5% weight loss, directly relevant to indication

Consistency

insufficient

No results reported; consistency cannot be assessed against other trials

Risk of bias

insufficient

Methods (blinding, allocation concealment, analysis plan) not detailed in registry record

Sample adequacy

moderate

675 participants estimated; adequacy depends on effect size assumptions not stated

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07670884). This is a study registration, not published results. Lead sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.. Recruitment status: RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 675 participants (ESTIMATED). Conditions: Chronic Management of Body Weight. Interventions: DRUG: HRS9531 Tablet; DRUG: HRS9531 Tablet Placebo. Primary outcome measures: Percentage change from baseline in body weight after 52 weeks of treatment , After 52 weeks of treatment.; Proportion of subjects with weight loss of ≥ 5% from baseline in body weight after 52 weeks of treatment , After 52 weeks of treatment.. Brief summary: This study aims to evaluate the efficacy and safety of HRS9531 tablets compared with placebo in reducing body weight in overweight or obese subjects after 52 weeks of treatment.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

HRS9531 TabletHRS9531 Tablet PlaceboNCT07670884Fujian Shengdi Pharmaceutical Co.Chronic Management of Body Weight