Current partner codePEPTIDESDE
NCT06649344·Phase 3·INTERVENTIONAL

A Study of HRS9531 Versus Semaglutide Once Weekly as Add-on Therapy to Metformin Monotherapy or in Combination With SGLT2 Inhibitors in Participants With Type 2 Diabetes

Status

Completed

Phase

Phase 3

Enrollment

884

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

The study is being conducted to evaluate the efficacy and safety of HRS9531 once weekly (QW) in subjects with type 2 diabetes mellitus not adequately controlled with metformin monotherapy or in combination with SGLT2 inhibitors compared to Semaglutide QW for 36 weeks and 52 weeks.

Interventions

Treatment arms and agents.

DRUG

HRS9531 Injection

HRS9531 injected subcutaneously once weekly.

DRUG

Semaglutide Injection

Semaglutide injected subcutaneously once weekly.

Timeline

From registration to results.

  1. First posted

    Oct 18, 2024

  2. Study start

    Oct 31, 2024

  3. Primary completion

    Jul 18, 2026

  4. Study completion

    Jul 18, 2026

  5. Results posted

    Not reported

  6. Registry updated

    Jul 30, 2026

Outcomes

What the study measures.

Primary outcomes

Change in HbA1c

Time frame · Week 0 to Week 36

Change from baseline in Glycosylated Haemoglobin after 36 weeks of treatment.

Secondary outcomes

Change in body weight

Time frame · Week 0 to Week 36

Change from baseline in body weight after 36 weeks of treatment.

Proportion of Subjects with HbA1c≤6.5%

Time frame · Week 0 to Week 36

Proportion of subjects with HbA1c≤6.5% after 36 weeks of treatment.

Proportion of Subjects with HbA1c<7%

Time frame · Week 0 to Week 36

Proportion of subjects with HbA1c\<7% after 36 weeks of treatment.

Change in FPG (fasting plasma glucose)

Time frame · Week 0 to Week 36

Change from baseline in FPG after 36 weeks of treatment.

Change in FPG (fasting plasma glucose)

Time frame · Week 0 to Week 52

Change from baseline in FPG after 52 weeks of treatment.

7-points SMPG profiles

Time frame · Week 0 to Week 36

Fluctuation of 7-point SMPG. Plasma glucose measured: before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner,120 minutes after start of dinner, before bedtime.

Incidence and severity of adverse events

Time frame · Week 0 to Week 52+4 weeks follow-up

Severity (mild, moderate and severe) is assessed by investigator.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

Inclusion Criteria: 1. Diagnosed with type 2 diabetes ≥ 90 days; 2. Stable daily dose(s) for ≥3months prior to screening of : 1) Any metformin formulations ≥1500 mg daily or maximum tolerated (≥1000mg daily). 2) Any metformin formulations ≥1500 mg daily or maximum tolerated (≥1000mg daily) with one type of SGLT-2 inhibitors; 3. Glycated hemoglobin was 7.5% ≤HbA1c ≤11.0%; 4. Female patients of childbearing potential and male patients must agree to use highly effective contraception during the trial and for at least 2 months after the last dose of the investigational medicinal drug. Female patients of childbearing potential must test negative for pregnancy at Visit 1 and not be breastfeeding. Exclusion Criteria: 1. Known or suspected allergy or intolerance to the investigational medicinal products or related products; 2. Acute complications of diabetes occurred during the previous 6 months; 3. Serious chronic complications of diabetes in the past; 4. Use other antidiabetic drugs for ≥3months prior to screening ; 5. Before screening, have disease or treatment that may affect weight; or any previous condition that may affect gastric emptying; or gastrointestinal surgery; 6. Participation in any clinical trial of an approved or non-approved investigational product/treatment within the last 3 months or 5 half-lives, whichever is longer, prior to screening; 7. Any conditions that the Investigator judges might not be suitable to participate in the trial.

Study locations

1 registered sites.

China. Showing up to 24 locations stored in the fast local snapshot.

Zhu Xianyi Memorial Hospital,Tianjin Medical University

Tianjin, Tianjin Municipality, China

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Semaglutide.

Related PeptideStat pages

Put the record in context.

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