Evaluate the Safety and Tolerability of Multiple Doses of JMT206 Injection in Obese Participants
Identify the Expanded Access Program, if Any. This is Required Unless the Expanded Access Type is "Individual Patients." A Randomized, Parallel, Double-blind, Placebo-controlled Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of JMT206 Injection Alone or in Combination With Semaglutide in Obese Participants
Use these resources to provide understandable information about this study to patients, families, and health care providers:
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- La phase 1
Contacts et emplacements
Coordonnées de l'étude
- Nom: Clinical Trials Information Group officer
- Numéro de téléphone: 86-0311-69085587
- E-mail: ctr-contact@mail.ecspc.com
Lieux d'étude
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Beijing, Chine
- Recrutement
- Peking University People's Hospital
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Contact:
- Linong Ji
- Numéro de téléphone: +86 13910978815
- E-mail: jiln@bjmu.edu.cn
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Age 18~65 (including threshold values), male or female participants;
- BMI ≥ 30 kg/m²;
- Weight change <5% within the 3 months prior to screening
- Voluntarily sign the informed consent form before the trial..
Exclusion Criteria:
1) Those known to have a history of allergy to any component or related preparations in the investigational drug and its excipients, or have severe allergic diseases or allergic constitution; 2) Participants with a history of diabetes mellitus or hypoglycemic episodes; 3) Obesity is related to medication or diseases; Or weight gain caused by non-fat content; or monogene mutationsobesity; 4) History of weight loss surgery and/or treatment within the past year; 5) History of severe gastrointestinal disease or gastrointestinal surgery, clinically significant gastric emptying abnormalities, or long-term use of medications directly affecting gastrointestinal motility; 6) Having comorbidities known to affect skeletal muscle proteins; 7) A history of acute or chronic pancreatitis; 8) Acute gallbladder disease within one year prior to screening; 9) Previous or family history of medullary thyroid carcinoma or type 2 endocrine adenomatosis; 10) Severe cardiovascular or cerebrovascular events within 6 months prior to screening; 11) Any type of treated or untreated malignant tumor within 5 years prior to screening; 12) History of severe mental illness; 13) Use of drugs or products that may cause weight changes within 3 months prior to screening; 14) Use of drugs or products affecting skeletal muscle synthesis within 3 months prior to screening; 15) Participants deemed otherwise unsuitable for this trial by the investigator.
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Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: JMT206 injection group 2
JMT206 injection dose 2 administered subcutaneously (SC) once a week |
JMT206 injection administered subcutaneously (SC) once a week |
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Expérimental: JMT206 injection group 3
JMT206 injection dose 3 administered subcutaneously (SC) once a week |
JMT206 injection administered subcutaneously (SC) once a week |
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Expérimental: JMT206 injection + Semaglutide group 1
JMT206 injection dose 1 administered subcutaneously (SC) once a week. Semaglutide administered subcutaneously once a week, starts from lower dose and is gradually increased. |
JMT206 injection administered subcutaneously (SC) once a week Semaglutide administered subcutaneously once a week, starts from lower dose and is gradually increased. |
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Expérimental: JMT206 injection + Semaglutide group 2
JMT206 injection dose 2 administered subcutaneously (SC) once a week. Semaglutide administered subcutaneously once a week, starts from lower dose and is gradually increased. |
JMT206 injection administered subcutaneously (SC) once a week Semaglutide administered subcutaneously once a week, starts from lower dose and is gradually increased. |
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Expérimental: JMT206 injection + Semaglutide group 3
JMT206 injection dose 3 administered subcutaneously (SC) once a week. Semaglutide administered subcutaneously once a week, starts from lower dose and is gradually increased |
JMT206 injection administered subcutaneously (SC) once a week Semaglutide administered subcutaneously once a week, starts from lower dose and is gradually increased. |
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Comparateur placebo: Placebo
Placebo administered subcutaneously (SC) once a week |
Placebo administered subcutaneously (SC) once a week. |
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Comparateur placebo: Placebo+ Semaglutide
Placebo administered subcutaneously (SC) once a week. Semaglutide administered subcutaneously once a week, starts from lower dose and is gradually increased. |
Semaglutide administered subcutaneously once a week, starts from lower dose and is gradually increased. Placebo administered subcutaneously (SC) once a week. |
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Expérimental: JMT206 injection group 1
JMT206 injection dose 1 administered subcutaneously (SC) once a week |
JMT206 injection administered subcutaneously (SC) once a week |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
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Incidence of Adverse Events (AE) assessed by CTCAE v6.0
Délai: Baseline through week 19
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Baseline through week 19
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- JMT206-003
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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