Continued Treatment With Tirzepatide for Maintenance of Weight Reduction in Adults With Obesity : The SURMOUNT-4 Randomized Clinical Trial
Importance: The effect of continued treatment with tirzepatide on maintaining initial weight reduction is unknown.
Objective: To assess the effect of tirzepatide, with diet and physical activity, on the maintenance of weight reduction.
Design, Setting, and Participants: This phase 3, randomized withdrawal clinical trial conducted at 70 sites in 4 countries with a 36-week, open-label tirzepatide lead-in period followed by a 52-week, double-blind, placebo-controlled period included adults with a body mass index greater than or equal to 30 or greater than or equal to 27 and a weight-related complication, excluding diabetes.
Interventions: Participants (n = 783) enrolled in an open-label lead-in period received once-weekly subcutaneous maximum tolerated dose (10 or 15 mg) of tirzepatide for 36 weeks. At week 36, a total of 670 participants were randomized (1:1) to continue receiving tirzepatide (n = 335) or switch to placebo (n = 335) for 52 weeks.
Main Outcomes and Measures: The primary end point was the mean percent change in weight from week 36 (randomization) to week 88. Key secondary end points included the proportion of participants at week 88 who maintained at least 80% of the weight loss during the lead-in period.
Results: Participants (n = 670; mean age, 48 years; 473 [71%] women; mean weight, 107.3 kg) who completed the 36-week lead-in period experienced a mean weight reduction of 20.9%. The mean percent weight change from week 36 to week 88 was -5.5% with tirzepatide vs 14.0% with placebo (difference, -19.4% [95% CI, -21.2% to -17.7%]; P < .001). Overall, 300 participants (89.5%) receiving tirzepatide at 88 weeks maintained at least 80% of the weight loss during the lead-in period compared with 16.6% receiving placebo (P < .001). The overall mean weight reduction from week 0 to 88 was 25.3% for tirzepatide and 9.9% for placebo. The most common adverse events were mostly mild to moderate gastrointestinal events, which occurred more commonly with tirzepatide vs placebo.
Conclusions and Relevance: In participants with obesity or overweight, withdrawing tirzepatide led to substantial regain of lost weight, whereas continued treatment maintained and augmented initial weight reduction.
Trial Registration: ClinicalTrials.gov Identifier: NCT04660643.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2024 |
|---|---|
| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:331 |
|---|---|
| Enthalten in: |
JAMA - 331(2024), 1 vom: 02. Jan., Seite 38-48 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Aronne, Louis J [VerfasserIn] |
|---|
| Links: |
|---|
| Anmerkungen: |
Date Completed 09.01.2024 Date Revised 20.04.2024 published: Print ClinicalTrials.gov: NCT04660643 Citation Status MEDLINE |
|---|
| doi: |
10.1001/jama.2023.24945 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM365696722 |
|---|
| LEADER | 01000caa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM365696722 | ||
| 003 | DE-627 | ||
| 005 | 20240420232209.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231226s2024 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1001/jama.2023.24945 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1381.xml |
| 035 | |a (DE-627)NLM365696722 | ||
| 035 | |a (NLM)38078870 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Aronne, Louis J |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Continued Treatment With Tirzepatide for Maintenance of Weight Reduction in Adults With Obesity |b The SURMOUNT-4 Randomized Clinical Trial |
| 264 | 1 | |c 2024 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 09.01.2024 | ||
| 500 | |a Date Revised 20.04.2024 | ||
| 500 | |a published: Print | ||
| 500 | |a ClinicalTrials.gov: NCT04660643 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Importance: The effect of continued treatment with tirzepatide on maintaining initial weight reduction is unknown | ||
| 520 | |a Objective: To assess the effect of tirzepatide, with diet and physical activity, on the maintenance of weight reduction | ||
| 520 | |a Design, Setting, and Participants: This phase 3, randomized withdrawal clinical trial conducted at 70 sites in 4 countries with a 36-week, open-label tirzepatide lead-in period followed by a 52-week, double-blind, placebo-controlled period included adults with a body mass index greater than or equal to 30 or greater than or equal to 27 and a weight-related complication, excluding diabetes | ||
| 520 | |a Interventions: Participants (n = 783) enrolled in an open-label lead-in period received once-weekly subcutaneous maximum tolerated dose (10 or 15 mg) of tirzepatide for 36 weeks. At week 36, a total of 670 participants were randomized (1:1) to continue receiving tirzepatide (n = 335) or switch to placebo (n = 335) for 52 weeks | ||
| 520 | |a Main Outcomes and Measures: The primary end point was the mean percent change in weight from week 36 (randomization) to week 88. Key secondary end points included the proportion of participants at week 88 who maintained at least 80% of the weight loss during the lead-in period | ||
| 520 | |a Results: Participants (n = 670; mean age, 48 years; 473 [71%] women; mean weight, 107.3 kg) who completed the 36-week lead-in period experienced a mean weight reduction of 20.9%. The mean percent weight change from week 36 to week 88 was -5.5% with tirzepatide vs 14.0% with placebo (difference, -19.4% [95% CI, -21.2% to -17.7%]; P < .001). Overall, 300 participants (89.5%) receiving tirzepatide at 88 weeks maintained at least 80% of the weight loss during the lead-in period compared with 16.6% receiving placebo (P < .001). The overall mean weight reduction from week 0 to 88 was 25.3% for tirzepatide and 9.9% for placebo. The most common adverse events were mostly mild to moderate gastrointestinal events, which occurred more commonly with tirzepatide vs placebo | ||
| 520 | |a Conclusions and Relevance: In participants with obesity or overweight, withdrawing tirzepatide led to substantial regain of lost weight, whereas continued treatment maintained and augmented initial weight reduction | ||
| 520 | |a Trial Registration: ClinicalTrials.gov Identifier: NCT04660643 | ||
| 650 | 4 | |a Clinical Trial, Phase III | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Multicenter Study | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 7 | |a Gastric Inhibitory Polypeptide |2 NLM | |
| 650 | 7 | |a 59392-49-3 |2 NLM | |
| 650 | 7 | |a tirzepatide |2 NLM | |
| 650 | 7 | |a OYN3CCI6QE |2 NLM | |
| 650 | 7 | |a Glucagon-Like Peptide-2 Receptor |2 NLM | |
| 650 | 7 | |a Incretins |2 NLM | |
| 650 | 7 | |a Anti-Obesity Agents |2 NLM | |
| 700 | 1 | |a Sattar, Naveed |e verfasserin |4 aut | |
| 700 | 1 | |a Horn, Deborah B |e verfasserin |4 aut | |
| 700 | 1 | |a Bays, Harold E |e verfasserin |4 aut | |
| 700 | 1 | |a Wharton, Sean |e verfasserin |4 aut | |
| 700 | 1 | |a Lin, Wen-Yuan |e verfasserin |4 aut | |
| 700 | 1 | |a Ahmad, Nadia N |e verfasserin |4 aut | |
| 700 | 1 | |a Zhang, Shuyu |e verfasserin |4 aut | |
| 700 | 1 | |a Liao, Ran |e verfasserin |4 aut | |
| 700 | 1 | |a Bunck, Mathijs C |e verfasserin |4 aut | |
| 700 | 1 | |a Jouravskaya, Irina |e verfasserin |4 aut | |
| 700 | 1 | |a Murphy, Madhumita A |e verfasserin |4 aut | |
| 700 | 0 | |a SURMOUNT-4 Investigators |e verfasserin |4 aut | |
| 700 | 1 | |a Fretes, José O |e investigator |4 oth | |
| 700 | 1 | |a Coronel, Maria J |e investigator |4 oth | |
| 700 | 1 | |a Gutnisky, Lucas L |e investigator |4 oth | |
| 700 | 1 | |a Frechtel, Gustavo D |e investigator |4 oth | |
| 700 | 1 | |a Gelersztein, Elizabeth |e investigator |4 oth | |
| 700 | 1 | |a Aizenberg, Diego |e investigator |4 oth | |
| 700 | 1 | |a Maldonado, Natacha |e investigator |4 oth | |
| 700 | 1 | |a Pereira, Márcio |e investigator |4 oth | |
| 700 | 1 | |a Santos, Queulla G |e investigator |4 oth | |
| 700 | 1 | |a Calil Salim, Camila |e investigator |4 oth | |
| 700 | 1 | |a Canani, Luis H |e investigator |4 oth | |
| 700 | 1 | |a Halpern, Bruno |e investigator |4 oth | |
| 700 | 1 | |a Russo, Luis At |e investigator |4 oth | |
| 700 | 1 | |a Bodart, Joselita |e investigator |4 oth | |
| 700 | 1 | |a Neto, Danilo V |e investigator |4 oth | |
| 700 | 1 | |a Augusto, Gustavo |e investigator |4 oth | |
| 700 | 1 | |a Leite, Silmara |e investigator |4 oth | |
| 700 | 1 | |a Yang, Yi-Ching |e investigator |4 oth | |
| 700 | 1 | |a Lin, Wen-Yuan |e investigator |4 oth | |
| 700 | 1 | |a Huang, Chien-Ning |e investigator |4 oth | |
| 700 | 1 | |a Huang, Kuo-Chin |e investigator |4 oth | |
| 700 | 1 | |a Fitz-Patrick, David |e investigator |4 oth | |
| 700 | 1 | |a Pau, Cindy Ht |e investigator |4 oth | |
| 700 | 1 | |a Toth, Phillip D |e investigator |4 oth | |
| 700 | 1 | |a Freeman, George H |e investigator |4 oth | |
| 700 | 1 | |a Gardner, Donald F |e investigator |4 oth | |
| 700 | 1 | |a Wynne, Alan G |e investigator |4 oth | |
| 700 | 1 | |a Loy, Juan |e investigator |4 oth | |
| 700 | 1 | |a Horn, Deborah B |e investigator |4 oth | |
| 700 | 1 | |a Mehra, Purvi K |e investigator |4 oth | |
| 700 | 1 | |a Layle, Stacey |e investigator |4 oth | |
| 700 | 1 | |a Bergthold, James H |e investigator |4 oth | |
| 700 | 1 | |a de Souza, Jose |e investigator |4 oth | |
| 700 | 1 | |a Nadar, Venkatesh K |e investigator |4 oth | |
| 700 | 1 | |a Albizu Angulo, Gustavo R |e investigator |4 oth | |
| 700 | 1 | |a Cohen, Kenneth R |e investigator |4 oth | |
| 700 | 1 | |a Smith, Timothy R |e investigator |4 oth | |
| 700 | 1 | |a Aronne, Louis J |e investigator |4 oth | |
| 700 | 1 | |a Vaughn, Michael |e investigator |4 oth | |
| 700 | 1 | |a Alcantara-Gonzalez, Altagracia A |e investigator |4 oth | |
| 700 | 1 | |a Forman, Seth B |e investigator |4 oth | |
| 700 | 1 | |a Agaiby, John M |e investigator |4 oth | |
| 700 | 1 | |a Geller, Steven A |e investigator |4 oth | |
| 700 | 1 | |a Fraser, Neil J |e investigator |4 oth | |
| 700 | 1 | |a Jenders, Robert A |e investigator |4 oth | |
| 700 | 1 | |a Barbel-Johnson, Kim M |e investigator |4 oth | |
| 700 | 1 | |a Mayfield, Ronald K |e investigator |4 oth | |
| 700 | 1 | |a Vance, Carl D |e investigator |4 oth | |
| 700 | 1 | |a Prier, Kevin T |e investigator |4 oth | |
| 700 | 1 | |a Murray, Alexander V |e investigator |4 oth | |
| 700 | 1 | |a Lillestol, Michael J |e investigator |4 oth | |
| 700 | 1 | |a Denham, Douglas S |e investigator |4 oth | |
| 700 | 1 | |a Park, Jean Y |e investigator |4 oth | |
| 700 | 1 | |a Klein, Eric J |e investigator |4 oth | |
| 700 | 1 | |a Bays, Harold E |e investigator |4 oth | |
| 700 | 1 | |a Philis-Tsimikas, Athena |e investigator |4 oth | |
| 700 | 1 | |a Bressler, Peter E |e investigator |4 oth | |
| 700 | 1 | |a Reed, John Ch |c 3rd |e investigator |4 oth | |
| 700 | 1 | |a Aslam, Shamaila |e investigator |4 oth | |
| 700 | 1 | |a Rosenstock, Julio |e investigator |4 oth | |
| 700 | 1 | |a Frias, Juan P |e investigator |4 oth | |
| 700 | 1 | |a Klaff, Leslie J |e investigator |4 oth | |
| 700 | 1 | |a Brazg, Ronald |e investigator |4 oth | |
| 700 | 1 | |a Gomez-Cuellar, Martha |e investigator |4 oth | |
| 700 | 1 | |a Connery, Lisa |e investigator |4 oth | |
| 700 | 1 | |a Van, Joanna T |e investigator |4 oth | |
| 700 | 1 | |a Selam, Jean-Louis |e investigator |4 oth | |
| 700 | 1 | |a Kim, John |e investigator |4 oth | |
| 700 | 1 | |a Blake, Dwight |e investigator |4 oth | |
| 700 | 1 | |a Gabriel, John |e investigator |4 oth | |
| 700 | 1 | |a Arora, Samir |e investigator |4 oth | |
| 700 | 1 | |a McCartney, Michael J |e investigator |4 oth | |
| 700 | 1 | |a Solano, Royce K |e investigator |4 oth | |
| 700 | 1 | |a Brodie, Steven K |e investigator |4 oth | |
| 700 | 1 | |a Nardandrea, John P |e investigator |4 oth | |
| 773 | 0 | 8 | |i Enthalten in |t JAMA |d 1948 |g 331(2024), 1 vom: 02. Jan., Seite 38-48 |w (DE-627)NLM000006939 |x 1538-3598 |7 nnns |
| 773 | 1 | 8 | |g volume:331 |g year:2024 |g number:1 |g day:02 |g month:01 |g pages:38-48 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1001/jama.2023.24945 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 331 |j 2024 |e 1 |b 02 |c 01 |h 38-48 | ||