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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Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Geschätzt)
Phase
- Phase 1
Kontakte und Standorte
Studienkontakt
- Name: Clinical Trials Information Group officer
- Telefonnummer: 86-0311-69085587
- E-Mail: ctr-contact@mail.ecspc.com
Studienorte
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Beijing, China
- Rekrutierung
- Peking University People's Hospital
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Kontakt:
- Linong Ji
- Telefonnummer: +86 13910978815
- E-Mail: jiln@bjmu.edu.cn
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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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Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: 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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Experimental: 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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Experimental: 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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Experimental: 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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Experimental: 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-Komparator: Placebo
Placebo administered subcutaneously (SC) once a week |
Placebo administered subcutaneously (SC) once a week. |
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Placebo-Komparator: 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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Experimental: JMT206 injection group 1
JMT206 injection dose 1 administered subcutaneously (SC) once a week |
JMT206 injection administered subcutaneously (SC) once a week |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
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Incidence of Adverse Events (AE) assessed by CTCAE v6.0
Zeitfenster: Baseline through week 19
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Baseline through week 19
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Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- JMT206-003
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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