{
 "page": "https://jabbitapp.com/research/wegovy-zepbound-ozempic-kids-teens-children-safety-evidence-teardown.html",
 "checked": "2026-10-27",
 "note": "Quotes asserted against cached copies. Chart values: Wegovy label Tables 3 and 5 and section 6.1 (gallbladder), Saxenda label Table 3, STEP TEENS NEJM 2022 abstract and Wegovy Table 18, SURPASS-PEDS Lancet 2025 abstract. Placebo arm first, drug second. Separate trials; not head-to-head. STEP Young figures are company-reported (Novo Nordisk, Sep 7 2026) and not peer-reviewed.",
 "pubmed_abstract_quotes": {
  "36322838": [
   "A total of 201 participants underwent randomization, and 180 (90%) completed treatment.",
   "The mean change in BMI from baseline to week 68 was -16.1% with semaglutide and 0.6% with placebo (estimated difference, -16.7 percentage points",
   "a total of 95 of 131 participants (73%) in the semaglutide group had weight loss of 5% or more, as compared with 11 of 62 participants (18%) in the placebo group",
   "The incidence of gastrointestinal adverse events was greater with semaglutide than with placebo (62% vs. 42%).",
   "Five participants (4%) in the semaglutide group and no participants in the placebo group had cholelithiasis.",
   "Serious adverse events were reported in 15 of 133 participants (11%) in the semaglutide group and in 6 of 67 participants (9%) in the placebo group.",
   "(Funded by Novo Nordisk; STEP TEENS ClinicalTrials.gov number, NCT04102189.)"
  ],
  "37196421": [
   "44.9% of participants receiving semaglutide achieved weight reduction resulting in reclassification to a normal-weight or overweight BMI category versus 12.1% receiving placebo at week 68",
   "The proportion of semaglutide-treated participants in obesity class III decreased from 37.3% to 13.6% but increased with placebo."
  ],
  "41296499": [
   "homeostatic model assessment for insulin resistance (HOMA-IR) score (-35.0% vs. -5.3%; P = 0.0002)",
   "alanine aminotransferase (ALT; -17.9% vs. -3.3%; P = 0.0232)"
  ],
  "32233338": [
   "A total of 125 participants were assigned to the liraglutide group and 126 to the placebo group.",
   "A greater reduction was observed with liraglutide than with placebo for BMI (estimated difference, -4.64 percentage points)",
   "After discontinuation, a greater increase in the BMI standard-deviation score was observed with liraglutide than with placebo (estimated difference, 0.15; 95% CI, 0.07 to 0.23).",
   "(81 of 125 [64.8%] vs. 46 of 126 [36.5%])",
   "adverse events that led to discontinuation of the trial treatment (13 [10.4%] vs. 0)",
   "One suicide, which occurred in the liraglutide group, was assessed by the investigator as unlikely to be related to the trial treatment.",
   "a 56-week treatment period and a 26-week follow-up period",
   "(Funded by Novo Nordisk; NN8022-4180 ClinicalTrials.gov number, NCT02918279.)"
  ],
  "40952752": [
   "In this systematic review and meta-analysis of 18 trials",
   "Other AEs, including suicidal ideation or behaviors, showed no significant differences.",
   "Available data over a relatively short follow-up suggested suicidal ideation or behaviors were not significantly different, although GI AEs warrant attention in long-term management."
  ],
  "39401009": [
   "Propensity score matching resulted in 3456 participants in each balanced cohort.",
   "(1.45% vs 2.26%; hazard ratio [HR], 0.67; 95% CI, 0.47-0.95; P = .02)"
  ],
  "42115753": [
   "We included 11 studies (9 RCTs, n = 1253; 2 observational, n = 8922; total n = 10 175).",
   "GLP-1 RAs were not associated with higher rates of suicidal behaviour or depression in adolescents.",
   "although this finding should be interpreted cautiously"
  ],
  "42736027": [
   "After propensity score matching, 9222 adolescents were included in each group.",
   "lower risks of suicide-related events (HR, 0.74; 95% CI, 0.57-0.95)",
   "No significant differences were observed for suicide attempt, insomnia, depression, or eating disorders.",
   "this finding should be interpreted cautiously given potential selection bias and the lack of a significant difference in the active-comparator analysis with metformin"
  ],
  "42508693": [
   "However, the developmental implications and long-term effects have yet to be evaluated.",
   "critical knowledge gaps remain regarding long-term effects of GLP-1RAs on growth, pubertal development, cognition, neural reward processing, and lifelong energy balance regulation"
  ],
  "40975112": [
   "99 (60 [61%] female, 39 [39%] male; mean age 14·7 years [SD 1·8]",
   "(estimated treatment difference -2·28%; 95% CI -2·87 to -1·69; p<0·0001)",
   "Tirzepatide also resulted in significant reductions in BMI of 7·4% and 11·2% for the 5 mg and 10 mg groups, respectively, compared with 0·4% in the placebo group at 30 weeks."
  ]
 },
 "jama_2024_dispensing_quotes": [
  "Between 2020 and 2023, the number of adolescents and young adults with GLP-1RA dispensing increased from 8722 to 60 567 (594.4%).",
  "The number of male adolescents with GLP-1RA dispensing increased from 692 to 4178 (503.8%) and the number of female adolescents increased from 961 to 6607 (587.5%).",
  "the absence of data regarding the health effects of long-term use",
  "IQVIA Longitudinal Prescri",
  "The first 3 are approved for type 2 diabetes in adolescents.",
  "Limitations of this study include lack of data on prescription indication, including whether it was used off label."
 ],
 "who_2026_10_07_quotes": [
  "7 October 2026",
  "WHO does not recommend pharmacological treatment, bariatric surgery (weight-loss surgery that changes the stomach or digestive tract) or weight-loss devices for children aged 0–9 years.",
  "For adolescents aged 10–19 years, treatment with approved medicines may be considered only when a supervized multimodal lifestyle programme has not achieved the desired results.",
  "In 2024, 170 million children and adolescents aged 5–19 years were living with obesity",
  "Obesity prevalence in this age group has quadrupled since 1990, rising from 2% to 8%.",
  "WHO strongly recommends structured dietary, physical activity and behaviour-changing interventions",
  "“The foundation of obesity care for children and adolescents is not medicine or surgery, but access to comprehensive support that enables healthy eating, physical activity and sustainable behaviour change,”"
 ],
 "novo_2026_09_07_quotes": [
  "40.4% * of those treated with semaglutide were no longer classified as having obesity ** at week 68, compared with none of those treated with placebo.",
  "At baseline, more than 85% of the children had either class II or III severe obesity",
  "Furthermore, no safety concerns were identified for growth or pubertal development.",
  "Detailed STEP Young results will be presented at The Obesity Society’s annual meeting ObesityWeek 2026, 14-17 November in Washington DC",
  "* Based on the trial product estimand: treatment effect if all children adhered to treatment",
  "The STEP Young trial is conducted according to regulatory authorities’ post marketing requirements",
  "investigating safety and efficacy of semaglutide compared with placebo in 165 children with obesity aged 6 to <12 years"
 ],
 "uga_2026_10_26_quotes": [
  "Oct 26, 2026",
  "They’re approved for 12-year-olds and older, but sometimes people are actually prescribing them even younger in special circumstances",
  "When these medications cause weight loss, are these kids also losing muscle mass?",
  "it’s also important to know that weight loss often rebounds when you go off the medication"
 ],
 "wegovy_label_2026_06_quotes": [
  "Revised: 06/2026",
  "Reference ID: 5819850",
  "Adults and pediatric patients aged 12 years and older with obesity.",
  "Pediatric patients aged 12 years and older treated with WEGOVY injection had greater incidences of cholelithiasis, cholecystitis, hypotension, rash, and urticaria compared to adults treated with WEGOVY",
  "The safety of WEGOVY tablets and WEGOVY 7.2 mg injection have not been established in pediatric patients",
  "cholelithiasis was reported by 3.8% of WEGOVY injection-treated patients and 0% placebo-treated patients. Cholecystitis was reported by 0.8% of WEGOVY injection-treated pediatric patients and 0% placebo-treated patients.",
  "cholelithiasis was reported by 1.6% of WEGOVY injection-treated patients and 0.7% of placebo-treated patients",
  "N=67 Injection (2.4 mg % Once Weekly) N=133 % Nausea 18 42 Vomiting 10 36 Diarrhea 19 22 Headache 16 17 Abdominal Pain 6 15",
  "N=1,261 Injection (2.4 mg % Once Weekly) N=2,116 % Nausea 16 44 Diarrhea 16 30 Vomiting 6 24",
  "201 pubertal pediatric patients aged 12 years and older",
  "After a 12-week lifestyle run-in period",
  "% change from baseline (LSMean)a 2.7 -14.7"
 ],
 "saxenda_label": {
  "set_id": "3946d389-0926-4f77-a708-0acb8153b143",
  "effective": "20260225",
  "quotes": [
   "Adults and pediatric patients aged 12 years and older with body weight greater than 60 kg and obesity.",
   "Placebo N=126 % SAXENDA N=125 % Nausea 14.3 42.4 Vomiting 4 34.4",
   "Pancreatitis was reported in 1 (0.8%) SAXENDA-treated patient and resulted in treatment discontinuation."
  ]
 },
 "zepbound_label": {
  "set_id": "487cd7e7-434c-4925-99fa-aa80b1cc776b",
  "effective": "20260828",
  "quotes": [
   "The safety and effectiveness of ZEPBOUND have not been established in pediatric patients."
  ]
 },
 "mounjaro_label": {
  "set_id": "d2d7da5d-ad07-4228-955f-cf7e355c8cc0",
  "effective": "20260827",
  "quotes": [
   "Pediatric Patients 10 Years of Age and Older with Type 2 Diabetes Mellitus",
   "with the exception of a higher incidence of vomiting, abdominal pain, and hypoglycemia"
  ]
 },
 "ozempic_injection_label": {
  "set_id": "adec4fd2-6858-4c99-91d4-531f5f2a2d79",
  "quotes": [
   "Safety and efficacy of OZEMPIC have not been established in pediatric patients."
  ]
 },
 "clinicaltrials_gov": {
  "NCT04102189": {
   "title": "A Research Study on How Well Semaglutide Works in Adolescents With Overweight or Obesity",
   "status": "COMPLETED",
   "enrollment": {
    "count": 201,
    "type": "ACTUAL"
   },
   "primary_completion": {
    "date": "2022-03-25",
    "type": "ACTUAL"
   },
   "completion": {
    "date": "2022-03-28",
    "type": "ACTUAL"
   },
   "sponsor": "Novo Nordisk A/S",
   "ages": [
    "12 Years",
    "17 Years"
   ]
  },
  "NCT05726227": {
   "title": "A Research Study on How Well Semaglutide Helps Children and Teenagers With Excess Body Weight Lose Weight",
   "status": "ACTIVE_NOT_RECRUITING",
   "enrollment": {
    "count": 212,
    "type": "ACTUAL"
   },
   "primary_completion": {
    "date": "2025-10-15",
    "type": "ACTUAL"
   },
   "completion": {
    "date": "2026-12-07",
    "type": "ESTIMATED"
   },
   "sponsor": "Novo Nordisk A/S",
   "ages": [
    "6 Years",
    "18 Years"
   ]
  },
  "NCT06075667": {
   "title": "A Study of Tirzepatide (LY3298176) Once Weekly in Adolescent Participants Who Have Obesity or Overweight With Weight-Related Comorbidities",
   "status": "ACTIVE_NOT_RECRUITING",
   "enrollment": {
    "count": 160,
    "type": "ACTUAL"
   },
   "primary_completion": {
    "date": "2026-06-02",
    "type": "ACTUAL"
   },
   "completion": {
    "date": "2029-07",
    "type": "ESTIMATED"
   },
   "sponsor": "Eli Lilly and Company",
   "ages": [
    "12 Years",
    "17 Years"
   ]
  },
  "NCT06439277": {
   "title": "A Study of Tirzepatide in Adolescents With Obesity and Weight-Related Comorbidities (SURMOUNT-ADOLESCENTS-2)",
   "status": "RECRUITING",
   "enrollment": {
    "count": 300,
    "type": "ESTIMATED"
   },
   "primary_completion": {
    "date": "2027-10",
    "type": "ESTIMATED"
   },
   "completion": {
    "date": "2030-12",
    "type": "ESTIMATED"
   },
   "sponsor": "Eli Lilly and Company",
   "ages": [
    "12 Years",
    "17 Years"
   ]
  },
  "NCT06571383": {
   "title": "STEP TEENS Weight Maintenance: A Research Study on How Well Semaglutide Helps Teenagers With Excess Body Weight to Lose Weight and Maintain Weight Loss",
   "status": "ACTIVE_NOT_RECRUITING",
   "enrollment": {
    "count": 500,
    "type": "ESTIMATED"
   },
   "primary_completion": {
    "date": "2028-11-15",
    "type": "ESTIMATED"
   },
   "completion": {
    "date": "2031-11-15",
    "type": "ESTIMATED"
   },
   "sponsor": "Novo Nordisk A/S",
   "ages": [
    "12 Years",
    "15 Years"
   ]
  }
 },
 "chart_data": {
  "side_effects_pct": [
   [
    "Vomiting, Wegovy (teens, STEP TEENS)",
    10,
    36
   ],
   [
    "Vomiting, Wegovy (adults)",
    6,
    24
   ],
   [
    "Vomiting, Saxenda (teens)",
    4,
    34.4
   ],
   [
    "Nausea, Wegovy (teens)",
    18,
    42
   ],
   [
    "Nausea, Wegovy (adults)",
    16,
    44
   ],
   [
    "Gallstones, Wegovy (teens)",
    0,
    3.8
   ],
   [
    "Gallstones, Wegovy (adults)",
    0.7,
    1.6
   ]
  ],
  "bmi_change_pct": [
   [
    "STEP TEENS: Wegovy, ages 12-17, 68 wk",
    0.6,
    -16.1
   ],
   [
    "SURPASS-PEDS: tirzepatide 5 mg, ages 10-17 with T2D, 30 wk",
    -0.4,
    -7.4
   ],
   [
    "SURPASS-PEDS: tirzepatide 10 mg, ages 10-17 with T2D, 30 wk",
    -0.4,
    -11.2
   ]
  ]
 }
}