Weight Changes After Incretin-mimetics
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: discontinuation of weight loss medication.
- Who it may be relevant to
- Registry conditions: Obesity and Obesity-related Medical Conditions. Basic parameters: 18 years — 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The goal of this study is to identify people at risk of weight regain after stopping an injectable weight loss drug. The main question the investigators aim to answer is: Can weight regain be predicted by measuring circulating Agouti-related peptide, a small protein coming from the brain?
Detailed description
This study will enroll people who are taking an injectable weight loss drug, have lost weight with the help of this drug, and are required by their health insurance plan to discontinue treatment. Participants will first be screened for health conditions that would prevent them from entering the study. Once enrolled, participants will be asked to have the following testing while still on the injectable weight loss drug: body weight measurement, body composition (fat and lean mass), resting energy expenditure (calories burned), multiple blood draws after overnight fast and after drinking and nutritional shake urine collection, urine collection, measurement of heart rate, measurement of physical activity and sleep, questionnaires. Participants will then stop taking the injectable weight loss drug when the prescription runs out, and the same tests will be repeated 3 months later.
Interventions
- Other discontinuation of weight loss medication
Participants will be studied right before their injectable weight loss medication runs out, and 3 months later
Primary outcome measures
- weight change [Time frame: 3 months]
- fasting and post-prandial circulating AgRP [Time frame: 3 months]
Secondary outcome measures (4)
- subjective hunger ratings [Time frame: 3 months]
- resting metabolic rate (RMR) [Time frame: 3 months]
- RMR adaptation [Time frame: 3 months]
- body composition [Time frame: 3 months]
Eligibility criteria
Inclusion criteria
- adults 18 years or older
- men and women
- prescribed an incretin-mimetic for weight loss and for whom insurance coverage for this specific drug will lapse
- any ethnicity
Exclusion criteria
- weight > or = 400 lb
- type 1 or type 2 diabetes
- patients taking steroid medications
- anemia
- heart disease
- advanced kidney disease (CKD stage 4 and 5)
- decompensated liver disease
- hyperthyroidism
- untreated hypothyroidism
- active cancer
- post solid organ or bone marrow transplant
- HIV/AIDS
- pregnancy/plan for pregnancy in the next 6 months
- breastfeeding
- post-menopausal women
- current smoker
- current recreational drug use
- night shift or rotating shift workers
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06795360 · PRO00052666