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
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Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Fase 1
Contacten en locaties
Studiecontact
- Naam: Clinical Trials Information Group officer
- Telefoonnummer: 86-0311-69085587
- E-mail: ctr-contact@mail.ecspc.com
Studie Locaties
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Beijing, China
- Werving
- Peking University People's Hospital
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Contact:
- Linong Ji
- Telefoonnummer: +86 13910978815
- E-mail: jiln@bjmu.edu.cn
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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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Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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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Experimenteel: 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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Experimenteel: 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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Experimenteel: 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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Experimenteel: 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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Placebo-vergelijker: Placebo
Placebo administered subcutaneously (SC) once a week |
Placebo administered subcutaneously (SC) once a week. |
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Placebo-vergelijker: 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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Experimenteel: JMT206 injection group 1
JMT206 injection dose 1 administered subcutaneously (SC) once a week |
JMT206 injection administered subcutaneously (SC) once a week |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Incidence of Adverse Events (AE) assessed by CTCAE v6.0
Tijdsspanne: Baseline through week 19
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Baseline through week 19
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Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- JMT206-003
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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