Are You Interested in Losing Weight? (In the Greater Seattle Area.)

  • STATUS
    Recruiting
Updated on 22 October 2021
dietary counseling
calorie diet
Accepts healthy volunteers

Summary

We are currently seeking volunteers to participate in a study of an investigational medication for weight loss.  The medication works as an appetite suppressant. 
Once a week, participants will inject the medication into their thigh, or abdomen by themselves. 

Qualified participants will be divided into one of two different groups:
  • 80% of all participants will begin taking the investigational medication, by injection once a week. 
  • The other 20% of all participants will begin taking a placebo injection once a week. 
All participants:
  • Will receive dietary counseling and physical activity counseling from a registered dietician.
  • Must be willing to maintain a semi-daily food and exercise diary (3-day food/exercise diary, to be completed between in-clinic visits) and will be encouraged to commit to some form of physical activity and reduced calorie diet during the study.
  • Have questionnaires evaluating patient status (mental & physical) at several visits.

Description

Study Length: 58 weeks, with 14 clinic visits and 4 telephone appointments.

Target Age: 18 – 75 years old.

Benefits: Participants will receive the following at no cost: 
Study medication, study related physical exams, EKGs, lab work, dietary and physical activity counseling, and other supplies.

Stipend: $TBD.

Details
Condition Weight Loss, Obesity
Clinical Study IdentifierTX275548
Last Modified on22 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

MUST BE ABLE TO MAKE IN-PERSON CLINIC VISITS TO OUR SITE IN RENTON, WASHINGTON
Participant must have a BMI between 30 – 50, or have a BMI between 27 – 29.99 and meet other qualifications
Participant must be well motivated to participate in this study, be willing to follow dietary restrictions and exercise plans, and be willing to perform all other requirements of study
Participant must be 18 to 75 years of age inclusive, at the time of signing the informed consent

Exclusion Criteria

Have history of type 1 diabetes mellitus (T1D) or type 2 diabetes mellitus (T2D), history of ketoacidosis, or hyperosmolar state/coma
Have at least 1 laboratory value suggestive of diabetes during screening, including 1 or more of HbA1c ≥6.5% (48 mmol/mol), fasting serum glucose ≥126 mg/dL (7.0 mmol/L), or random glucose ≥200 mg/dL (11.1 mmol/L)
Have a self-reported change (increase or decrease) in body weight >5 kg within 3 months prior to screening
Have a prior or planned surgical treatment or device-based therapy for obesity (excluding liposuction or abdominoplasty, if performed >1 year prior to screening)
Participants must meet other eligibility criteria
Please contact us for further details
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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