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Die klinische Studie NCT07481747 (SURMOUNT-1) für Fettleibigkeit, Overweight (Without Type 2 Diabetes) With Weight-related Comorbidities ist offene rekrutierung. In der Kartenansicht des Klinische Studien Radar und den KI-Entdeckungstools finden Sie alle Details. Oder stellen Sie hier Ihre Fragen. | ||
Eine Studie entspricht den Filterkriterien
Kartenansicht
Efficacy and Safety of Tirzepatide Once Weekly Versus Placebo in Participants Who Are Either Obese or Overweight With Weight-Related Comorbidities (SURMOUNT-1) Phase 3 2.539 Ernährung
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Die klinische Studie NCT07481747 (SURMOUNT-1) untersucht Behandlung im Zusammenhang mit Fettleibigkeit, Overweight (Without Type 2 Diabetes) With Weight-related Comorbidities. Diese interventionsstudie der Phase 3 hat den Status offene rekrutierung und startete am 2. Februar 2026. Es ist geplant, 2.539 Teilnehmer aufzunehmen. Durchgeführt von Hudson Biotech wird der Abschluss für 17. März 2028 erwartet. Die Daten von ClinicalTrials.gov wurden zuletzt am 19. März 2026 aktualisiert.
Kurzbeschreibung
This Phase 3 study evaluates the efficacy and safety of once-weekly subcutaneous tirzepatide (a dual GIP and GLP-1 receptor agonist) at 5 mg, 10 mg, or 15 mg versus placebo, each used with a reduced-calorie diet and increased physical activity, in adults without type 2 diabetes who have obesity or are overweight with weight-related comorbidities. The primary efficacy assessment is at Week 72. Participants with predia...Mehr anzeigen
Ausführliche Beschreibung
After screening, eligible participants are randomized in a 1:1:1:1 ratio to receive tirzepatide 5 mg, 10 mg, 15 mg, or placebo once weekly by subcutaneous injection using an autoinjector. All participants receive lifestyle counseling focused on a reduced-calorie diet and increased physical activity. The main treatment period is 72 weeks. Participants identified with prediabetes at randomization can continue study tre...Mehr anzeigen
Offizieller Titel
Efficacy and Safety of Tirzepatide Once Weekly in Participants Without Type 2 Diabetes Who Have Obesity or Are Overweight With Weight-Related Comorbidities: A Randomized, Double-Blind, Placebo-Controlled Trial (SURMOUNT-1)
Erkrankungen
FettleibigkeitOverweight (Without Type 2 Diabetes) With Weight-related ComorbiditiesWeitere Studien-IDs
- SURMOUNT-1
- I8F-MC-GPHK(b)
NCT-Nummer
Studienbeginn (tatsächlich)
2026-02-02
Zuletzt aktualisiert
2026-03-19
Studienende (vorauss.)
2028-03-17
Geplante Rekrutierung
2.539
Studientyp
Interventionsstudie
PHASE
Phase 3
Status
Offene Rekrutierung
Stichwörter
Tirzepatide
LY3298176
dual incretin
GIP
GLP-1
obesity
overweight
weight management
placebo
randomized
double-blind
once-weekly
subcutaneous
lifestyle intervention
LY3298176
dual incretin
GIP
GLP-1
obesity
overweight
weight management
placebo
randomized
double-blind
once-weekly
subcutaneous
lifestyle intervention
Primäres Ziel
Behandlung
Zuteilungsmethode
Randomisiert
Interventionsmodell
Parallel
Verblindung
Doppelt verblindet
Studienarme/Interventionen
| Teilnehmergruppe/Studienarm | Intervention/Behandlung |
|---|---|
ExperimentellArm 1: Tirzepatide 5 mg once weekly + lifestyle intervention | Tirzepatide (once-weekly SC injection; doses 5/10/15 mg) PLACEBO (once-weekly SC injection) Reduced-calorie diet increased physical activity counseling |
ExperimentellArm 2: Tirzepatide 10 mg once weekly + lifestyle intervention | Tirzepatide (once-weekly SC injection; doses 5/10/15 mg) PLACEBO (once-weekly SC injection) Reduced-calorie diet increased physical activity counseling |
ExperimentellArm 3: Tirzepatide 15 mg once weekly + lifestyle intervention | Tirzepatide (once-weekly SC injection; doses 5/10/15 mg) PLACEBO (once-weekly SC injection) Reduced-calorie diet increased physical activity counseling |
ExperimentellArm 4: Placebo once weekly + lifestyle intervention | Tirzepatide (once-weekly SC injection; doses 5/10/15 mg) PLACEBO (once-weekly SC injection) Reduced-calorie diet increased physical activity counseling |
Hauptergebnismessungen
Nebenergebnismessungen
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
Mean percent change in body weight from randomization | 72 Weeks | |
Percentage of participants achieving ≥5% body weight reduction from randomization | 72 Weeks |
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
Mean change in body weight | Mean change in body weight (kg) from randomization (pooled 10 mg and 15mg vs placebo) | 72 Weeks |
Changes in cardiometabolic measures in triglycerides | 72 weeks |
Teilnahme-Assistent
Eignungskriterien
Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Alle
- BMI ≥30 kg/m², OR BMI ≥27 kg/m² with ≥1 weight-related comorbidity (e.g., hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease)
- History of at least one unsuccessful dietary effort to lose weight (self-reported)
- Investigator judges participant capable and willing to self-inject (or have assistance), follow lifestyle advice, maintain a diary, and complete questionnaires
- Age ≥18 years
- Meets protocol contraception/pregnancy criteria (as applicable) and provides written informed consent
- Type 1 or type 2 diabetes, history of ketoacidosis/hyperosmolar state, or screening labs diagnostic of diabetes
- Recent significant weight change (>5 kg within 3 months prior to screening)
- Prior/planned bariatric surgery; recent/ongoing endoscopic or device-based obesity therapies
- Severe renal impairment (eGFR <30 mL/min/1.73 m²)
- Clinically significant gastric emptying abnormality or chronic use of drugs that directly affect GI motility
- History of chronic or acute pancreatitis
- Clinically significant thyroid abnormalities at screening (e.g., TSH outside protocol range) or anticipated need to initiate thyroid replacement during study
- Obesity due to other endocrinologic disorders (e.g., Cushing syndrome) or monogenic/syndromic obesity (e.g., MC4R deficiency, Prader-Willi syndrome)
- Significant unstable major depressive disorder/severe psychiatric disorder, lifetime suicide attempt, or concerning suicidality screening (PHQ-9/C-SSRS criteria)
- Uncontrolled hypertension; recent major cardiovascular events; NYHA class IV heart failure
- Active or significant liver disease or certain elevated liver tests at screening (per protocol thresholds)
- Elevated calcitonin above protocol thresholds; personal/family history of medullary thyroid carcinoma or MEN2
- Active/untreated malignancy or remission <5 years (with specified exceptions)
- Any other condition contraindicating GLP-1 receptor agonist therapy
Hudson BiotechZentrale Studienkontakte
Kontakt: Seni S Lu, Phd, +86 13076790030, [email protected]
1 Studienstandorte in 1 Ländern
Guangdong
Peking University Shenzhen Hospital, Shenzhen, Guangdong, 518036, China
Zhen J Peng, Phd, Kontakt, +86 13076790039, [email protected]
Offene Rekrutierung