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Delfa

← All trials/NCT07812597

Not yet recruitingPhase 2

A Study Evaluating Safety and Tolerability of Switching From Semaglutide to Zovaglutide in Adults With Obesity (HORIZON-SWITCH-SZ)

A Multicenter, Randomized, Active-Controlled, Open-Label Phase IIb Study Evaluating Safety and Tolerability of Switching to Zovaglutide Injection After Titration to 2.4 mg Semaglutide Injection (Wegovy®) in Adults With Obesity (HORIZON-SWITCH-SZ)

Assets

Semaglutide / Zovaglutide

Listed sites

16

Recruiting sites

-

Estimated enrollment

210

Study population

Obesity / overweight

Eligibility highlights

•BMI ≥28

Primary endpoint

•Successful switch from semaglutide 2.4 mg to zovaglutide after randomization

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07812597
Org study IDBJQL-ZT002-2003

Timeline

Milestones

Study first posted2026-09-10actual
Last update posted2026-09-10actual
Study start2026-10-12estimated
Primary completion2028-01-13estimated
Study completion2028-03-24estimated

Assets

Investigational agents

Who this study enrolls

Obesity / overweight

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Male or female subjects aged≥18years and≤75 years at the time of signing the Informed Consent Form (ICF).
•At screening, Body Mass Index (BMI)≥28kg/m²
•Weight change due to diet and exercise alone within 3 months prior to screening did not exceed 5%.

Exclusion criteria

•Previously diagnosed obesity caused by monogenic mutations, other diseases, or medications.
•Previous diagnosis of diabetes; or HbA1c ≥ 6.5% or fasting blood glucose ≥ 7.0 mmol/L at screening.
•Used of medicines or treatments that affect weight within 3 months prior to screening.
•History of acute or chronic pancreatitis, or pancreatic injury.
•History of medullary thyroid carcinoma (MTC) or type 2 multiple endocrine neoplasia (MEN2) in personal or family history.
•History of medullary thyroid carcinoma (MTC) or type 2 multiple endocrine neoplasia (MEN2) in personal or family history.
•Patient Health Questionnaire-9 (PHQ-9) scale score is ≥ 15 at screening
•Screening Columbia-Suicide Severity Rating Scale(C-SSRS) questionnaire suicide ideation response of "Category 4 or 5," or any "yes" response to suicidal behavior questions

Endpoints (6)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)
3
Weight & body composition
1
Safety / tolerability / PK
1
Other clinical outcomes
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Changes in body weight from randomization

Time frame:from week 20 ( randomization) to week 36

descriptive

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

Proportion of participants achieving successful switch without severe gastrointestinal adverse event (GIAE)

Time frame:from week 20 (randomization) to week 36

threshold achievement, event

Other clinical outcomes

1 endpoint
Secondary/protocol endpoint

Incidence of GIAE

Time frame:from week 20 (randomization) to week 40

event count, event

Other (unclassified)

3 endpoints
Primary/protocol endpoint/low confidence

Proportion of participants achieving successful switch from semaglutide 2.4 mg to zovaglutide after randomization

Time frame:from week 20 (randomization) to week 36

threshold achievement, improvement

Secondary/protocol endpoint/low confidence

Proportion of participants achieving successful switch without dose modification

Time frame:from week 20 (randomization) to week 36

threshold achievement, improvement

Secondary/protocol endpoint/low confidence

Percentage of GIAE-free duration relative to total period after randomization

Time frame:from week 20 (randomization) to week 40

ratio, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateNovember 5, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the November 5, 2026 snapshot.