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60 Participants NeededMy employer runs this trial

Semaglutide Nasal Spray for Obesity

GH
Overseen ByGuiyi Huang, Master
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Shanghai World Leader Pharmaceutical Co., Ltd.
Must not be taking: Anti-obesity, Antidiabetics, Antidepressants, Antipsychotics
Disqualifiers: Diabetes, Bariatric surgery, Thyroid disease, Cardiovascular events, Psychiatric illness, others
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

Inclusion Criteria

Participants 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
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)
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Exclusion Criteria

I have not had any cancer in the past 5 years, except for certain cured early cancers.
I have nasal issues like ulcers, sinusitis, or polyps that could affect nasal treatments.
Participants with clinically significant abnormalities during nasal examination (including external nose and nasal cavity inspection) as determined by the investigator at screening
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single-dose administration of Semaglutide Nasal Spray or placebo

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety, tolerability, and pharmacokinetics after administration

36 days
Multiple visits (in-person and/or virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • Semaglutide Nasal Spray

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Active Control

Group I: Cohort A2:Semaglutide nasal spray and placeboExperimental Treatment2 Interventions
Group II: Cohort A1: Semaglutide nasal spray and placeboExperimental Treatment2 Interventions
Group III: Cohort A0 : Semaglutide Nasal SprayExperimental Treatment1 Intervention
Group IV: Cohort A3: Semaglutide injectionActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Shanghai World Leader Pharmaceutical Co., Ltd.

Lead Sponsor

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