Phase 1 Clinical Study of MWN117 Injection in Healthy Participants and Participants With Obesity
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorShanghai Minwei Biotechnology Co., Ltd
About this trial
This study is a randomized, double-blind, placebo-controlled, single-dose, dose-escalation Phase 1 clinical trial to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of MWN117 injection in healthy and obese Chinese participants.
The study consists of two parts. Part A includes two dose cohorts enrolling healthy participants, and Part B includes four dose cohorts enrolling obese participants. A total of 48 participants will be enrolled. Within each dose cohort, participants will be randomly assigned to receive a single subcutaneous injection of MWN117 or matching placebo.
The primary endpoint is safety, assessed by adverse events and related examinations. Secondary endpoints include plasma pharmacokinetic (PK) parameters and urine PK parameters.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Aged 18 to 55 years (inclusive) at the time of informed consent signing; male or female.
Body mass index (BMI): Part A, healthy participants, 20.0-27.9 kg/m² (inclusive); Part B, obese participants, 28.0-35.0 kg/m² (inclusive), with body weight > 60 kg for males and > 50 kg for females.
Stable weight for 3 months prior to screening (self-reported weight change ≤ 5%), with no major changes in diet or physical activity, and the ability to maintain a stable lifestyle during the study.
Participants and their sexual partners must have no plans for pregnancy or sperm/oocyte donation from the time of ICF signing until at least 12 months post-dose; participants must use effective non-pharmacological contraception during this period. Female participants of childbearing potential must have a negative serum pregnancy test at screening.
Disqualifiers
Use of GLP-1 receptor agonists (e.g., liraglutide, semaglutide, tirzepatide) within 3 months prior to screening.
Use of medications significantly affecting body weight within 3 months prior to screening, including but not limited to: orlistat, lorcaserin, phentermine/topiramate, naltrexone/bupropion, weight-affecting herbal products, or meal replacements; cumulative or continuous use of systemic steroids ≥ 14 days (IV/oral), tricyclic antidepressants, psychiatric medications, or sedatives (e.g., imipramine, amitriptyline, mirtazapine, paroxetine, phenelzine, chlorpromazine, thioridazine, clozapine, olanzapine, valproic acid, lithium).
Endocrine disorders that may significantly affect body weight (e.g., Cushing's syndrome, hypothyroidism, or hyperthyroidism), or drug-induced, monogenic, or genetic obesity syndromes.
History of surgery or device treatment for overweight or obesity.
Trial design
Design model
Parallel
Treatments tested in this trial
MWN117
DrugA1, A2; administered subcutaneously (SC)
MWN117
DrugB1, B2, B3, B4; administered SC
Placebo
Drugadministered SC
Treatment groups
48 Participants
are divided into 2 treatment groupsGroup A: Part AExperimental treatment 2 interventions
Group B: Part BExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Incidence of Adverse Events (AEs)
The incidence of adverse Events (AEs) and serious adverse events (SAEs).
Time frame
Up to Day 169Secondary outcomes
1
Area Under the Curve From Time 0 to the Last Measurable Time Point (AUC0-last)
AUC0-last of MWN117.
Time frame
Up to 48 hours post-dose2
Area Under the Curve From Time 0 to Infinity (AUC0-inf)
AUC0-inf of MWN117.
Time frame
Up to 48 hours post-dose3
Maximum Plasma Concentration (Cmax)
Cmax of MWN117.
Time frame
Up to 48 hours post-dose4
Time to Reach Maximum Plasma Concentration (Tmax)
Tmax of MWN117.
Time frame
Up to 48 hours post-doseSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: