A Clinical Study of Semaglutide Nasal Spray in Overweight or Obese Adults

Recruiting now · Phase 1 · Has a placebo group

Conditions studied: Overweight, Obesity

In brief

The specific aim of this study is to examine the Safety, Tolerability and Pharmacokinetic of Semaglutide Nasal Spray compared with placebo and positive control in Adult Overweight or Obese Participants.

Key facts

Study ID

NCT07465965

Run by

Shanghai World Leader Pharmaceutical Co., Ltd.

People needed

60

Starts

2026-03-02

Expected to finish

2026-08-30

Last updated by the study team

2026-03-12

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female participants aged ≥18 years and ≤ 65 years.
• Body Mass Index (BMI) at screening between 27.0 and 35.0 kg/m² (inclusive).
• Weight change of no more than ±5% during the 3 months prior to screening with diet and exercise alone (self-reported).
• Participants (including males) must have no plans for conception during the study and within 3 months after the last administration, and must agree to use effective contraceptive methods and refrain from donating sperm or eggs during this period.
• Negative anti-HIV antibody test result at screening.
• Participants must fully understand the trial objectives, nature, procedures, and potential adverse reactions, voluntarily participate, be able to communicate well with the investigators, comply with all study requirements, and sign the informed consent form before any study procedures begin.

You may not qualify if…

• Diagnosis of type 1, type 2, or other forms of diabetes mellitus.
• Prior diagnosis of obesity caused by monogenic mutations or other medical conditions, including but not limited to hypothalamic obesity, pituitary obesity, hypothyroidism-related obesity, Cushing's syndrome, insulinoma, acromegaly, or hypogonadism.
• Prior history of bariatric surgery (excluding participants who had liposuction, abdominoplasty, intragastric balloon removal, or duodenal-jejunal bypass sleeve removal >1 year prior), or plan to undergo bariatric surgery or use weight-loss devices during the study.
• Use of any of the following treatments within 3 months prior to screening:
• Approved or unapproved anti-obesity medications (e.g., liraglutide, semaglutide, benaglutide, tirzepatide, orlistat, phentermine/topiramate, naltrexone/bupropion), or herbal supplements, health products, meal replacements, or weight-loss capsules that may affect body weight;
• Any glucagon-like peptide-1 (GLP-1) receptor agonists, GLP-1 related multi-agonists (e.g., GLP-1/glucose-dependent insulinotropic polypeptide [GIP] dual agonists, GLP-1/glucagon [GCG] dual agonists, GLP-1/GIP/GCG triple agonists), or combination preparations containing GLP-1 receptor agonists;
• Any antidiabetic medications (e.g., odium-glucose cotransporter-2 inhibitors (SGLT2) inhibitors, metformin, alpha-glucosidase inhibitors, insulin);
• Any other treatments known to affect body weight (e.g., cause weight loss or weight gain), including:
• Systemic corticosteroid therapy (intravenous or oral) for >1 week
• Tricyclic antidepressants (e.g., imipramine, amitriptyline, doxepin)
• Selective serotonin reuptake inhibitors (SSRIs) (e.g., fluoxetine, paroxetine, sertraline, fluvoxamine)
• Antipsychotics/antiepileptics (e.g., imipramine, amitriptyline, mirtazapine, phenelzine, chlorpromazine HCl, clozapine, olanzapine, valproate derivatives, lithium preparations, thioridazine)
• Antihistamines (e.g., cyproheptadine, ketotifen, astemizole).
• Any investigational drugs, vaccines, or medical devices.
• Laboratory abnormalities at screening meeting any of the following:
• Glycated hemoglobin (HbA1c) ≥6.5% or fasting glucose ≥7.0 mmol/L;
• Uncontrolled hypertension, systolic blood pressure (SBP) ≥160 mmHg and/or diastolic blood pressure (DBP) ≥100 mmHg;
• Thyroid-stimulating hormone (TSH) >4.2 or <0.27 mIU/L;
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥1.5 × upper limit of normal (ULN), or total bilirubin ≥1.5 × ULN;
• Fasting triglycerides >3.42 mmol/L;
• Serum amylase or lipase ≥1.5×ULN;
• Calcitonin > ULN;
• Estimated glomerular filtration rate (eGFR) ≤80 mL/min/1.73 m²;
• Clinically significant ECG findings: HR <40 or >100 bpm, second- or third- degree atrioventricular (AV) block, long QT syndrome, QTcF >450 ms (male) or >470 ms (female), left bundle branch block (LBBB), complete right bundle branch block (RBBB), Wolff-Parkinson-White (WPW) syndrome, or other clinically significant arrhythmias (e.g., paroxysmal supraventricular tachycardia (SVT), atrial flutter/fibrillation, ventricular flutter or fibrillation, sick sinus syndrome) deemed unsuitable by the investigator.
• History of acute or chronic pancreatitis, or symptomatic gallbladder disease (except cholecystectomy).

Where it is running

• Frontage Clinical Services, Inc. — Secaucus, New Jersey, United States (enrolling)

Full record on ClinicalTrials.gov

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