New hope for young adults with stubborn obesity: drug boosts weight loss
NCT ID NCT05574439
First seen Jun 27, 2026 · Last updated Jul 09, 2026 · Updated 2 times
Summary
This study tested whether adding the drug semaglutide to lifestyle counseling helps young adults (ages 18-28) with obesity who previously did not lose enough weight through diet and exercise alone. About 246 participants were split into groups based on their past response to lifestyle treatment. Those who had not lost enough weight were given either semaglutide or a placebo for 68 weeks. The main goal was to see if semaglutide could reduce body mass index (BMI) more than placebo.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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246 people
The number who actually took part.
- Started
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May 2022
- Finished
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Apr 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 28 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age 18-28 years * The period from the initial treatment with TCOC protocol until inclusion in the study must be within 15 years. * Group A: BMI≥30. Non-responders: No BMI SDS reduction (≤0.1 BMI SDS) during TCOC protocol for more than one year and still have obesity. * Group B: BMI≥30. Insufficient responders: BMI SDS reduction ≥0.25 BMI SDS during TCOC protocol for more than one year, but still have obesity. * Group C: BMI≤30. Excellent responders: BMI SDS reduction ≥0.5 BMI SDS during TCOC protocol for more than one year and no longer have obesity. * Group D: Young adults who have participated in The Holbaek Study and have had normal weight development during childhood Exclusion Criteria: * Participants diagnosed with known serious chronic illness including type 1 or 2 diabetes (or a randomly measured fasting plasma glucose \>7 mmol/l) * Angina pectoris, coronary heart disease, congestive heart failure (NYHA III-IV) * Severe renal impairment (creatinine clearance (GFR) \<30 mL/min) * Severe hepatic impairment * Inflammatory bowel disease * Diabetic gastroparesis * Cancer * Chronic obstructive lung disease * Severe psychiatric disease, a history of major depressive or other severe psychiatric disorders * Use of medications causing clinically significant weight gain or loss * Previous bariatric surgery * A history of idiopathic acute pancreatitis * A family or personal history of multiple endocrine neoplasia type 2 or familial medullary thyroid carcinoma * Pregnancy, expecting pregnancy or breastfeeding. If a study participant is in doubt whether she could be pregnant, a urine pregnancy test is performed. Women with reproductive potential who are not using adequate contraceptive methods (combined oral contraceptive pill, progestin-only contraceptive pill, condoms, intrauterine device, injection, implant, or sterilization). Adequate contraception must be used throughout the study period and at least 2 months after discontinuation of trial medication (semaglutide will be present in the circulation for 5-7 weeks after the last dose). * Allergy to any of the ingredients/excipients of the study medication: Semaglutide, disodium phosphate dihydrate, propylene glycol, phenol, hydrochloric acid, sodium hydroxide. * Exclusion criteria for MRI: Pacemaker, claustrophobia, metal splinters or any other magnetic devices that cannot be removed prior to the scan (Participants can join the trial without MR scan)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Holbæk University Hospital
Holbæk, Region Zeeland, 4300, Denmark
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University of Copenhagen, Department of Biomedical Sciences
Copenhagen, 2200, Denmark
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Other studies related to the condition(s) this trial covers.
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