Evidence map›Paper›PMID 37351564›Full record

Trial reportThe New England journal of medicine2023

Daily Oral GLP-1 Receptor Agonist Orforglipron for Adults with Obesity.

Sean Wharton, Thomas Blevins, Lisa Connery, Julio Rosenstock, Sohini Raha, Rong Liu, Xiaosu Ma, Kieren J Mather, Axel Haupt, Deborah Robins and 4 more

2 registry-linked trialsAbstract readClinical Trial, Phase IRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in The New England journal of medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 215 papers, 15 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
215citing papers in PubMed, 15 pooled it
79.4field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT07731256 phase2not yet recruitingstarted 2027, after this paper: background citation

A Randomized-Controlled Trial of Semaglutide for Patients With Chronic Low Back Pain and Obesity

Ran2027Enrolled250Registered outcomes13Posted comparisons0ConditionsChronic Lower Back Pain, glp1 Agonist, Lower Back Pain, Obesity (BMI>30)ArmsPlacebo (administered by PDS290 pen-injector), Semaglutide (administered by PDS290 pen-injector)
PMID 39476339PMID 37385275PMID 32125402PMID 20007994PMID 27537761PMID 28192789PMID 29573870PMID 31797139PMID 32520773PMID 34051018PMID 35507483PMID 35606809other papers from this trial
Open the trial in the graph
NCT05051579 phase2completednot on this map

A Phase 2 Study of Once-Daily LY3502970 Compared With Placebo in Participants Who Have Obesity or Are Overweight With Weight-Related Comorbidities

TypeinterventionalSponsorEli Lilly and CompanyRan2021 to 2022Enrolled272ConditionsObesity, Overweight and ObesityArmsLY3502970, Placebo
3 · Its place in the literature

Who cites it

215 citing papers in PubMed, 15 syntheses or guidelines pooled it, 395 citations in OpenAlex.

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155 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors at 5 institutions in 2 countries.

Sean WhartonFrom McMaster University, York University, and Wharton Weight Management Clinic - all in Toronto (S.W.); Texas Diabetes and Endocrinology, Austin (T.B.), and Velocity Clinical Research at Medical City, Dallas (J.R.) - both in Texas; Alliance for Multispecialty Research, Norman, OK (L.C.); and Eli Lilly, Indianapolis (S.R., R.L., X.M., K.J.M., A.H., D.R., E.P., C.K., M.K.).
Thomas BlevinsFrom McMaster University, York University, and Wharton Weight Management Clinic - all in Toronto (S.W.); Texas Diabetes and Endocrinology, Austin (T.B.), and Velocity Clinical Research at Medical City, Dallas (J.R.) - both in Texas; Alliance for Multispecialty Research, Norman, OK (L.C.); and Eli Lilly, Indianapolis (S.R., R.L., X.M., K.J.M., A.H., D.R., E.P., C.K., M.K.).
Lisa ConneryFrom McMaster University, York University, and Wharton Weight Management Clinic - all in Toronto (S.W.); Texas Diabetes and Endocrinology, Austin (T.B.), and Velocity Clinical Research at Medical City, Dallas (J.R.) - both in Texas; Alliance for Multispecialty Research, Norman, OK (L.C.); and Eli Lilly, Indianapolis (S.R., R.L., X.M., K.J.M., A.H., D.R., E.P., C.K., M.K.).
Julio RosenstockFrom McMaster University, York University, and Wharton Weight Management Clinic - all in Toronto (S.W.); Texas Diabetes and Endocrinology, Austin (T.B.), and Velocity Clinical Research at Medical City, Dallas (J.R.) - both in Texas; Alliance for Multispecialty Research, Norman, OK (L.C.); and Eli Lilly, Indianapolis (S.R., R.L., X.M., K.J.M., A.H., D.R., E.P., C.K., M.K.).
Sohini RahaFrom McMaster University, York University, and Wharton Weight Management Clinic - all in Toronto (S.W.); Texas Diabetes and Endocrinology, Austin (T.B.), and Velocity Clinical Research at Medical City, Dallas (J.R.) - both in Texas; Alliance for Multispecialty Research, Norman, OK (L.C.); and Eli Lilly, Indianapolis (S.R., R.L., X.M., K.J.M., A.H., D.R., E.P., C.K., M.K.).
Rong LiuFrom McMaster University, York University, and Wharton Weight Management Clinic - all in Toronto (S.W.); Texas Diabetes and Endocrinology, Austin (T.B.), and Velocity Clinical Research at Medical City, Dallas (J.R.) - both in Texas; Alliance for Multispecialty Research, Norman, OK (L.C.); and Eli Lilly, Indianapolis (S.R., R.L., X.M., K.J.M., A.H., D.R., E.P., C.K., M.K.).
Xiaosu MaFrom McMaster University, York University, and Wharton Weight Management Clinic - all in Toronto (S.W.); Texas Diabetes and Endocrinology, Austin (T.B.), and Velocity Clinical Research at Medical City, Dallas (J.R.) - both in Texas; Alliance for Multispecialty Research, Norman, OK (L.C.); and Eli Lilly, Indianapolis (S.R., R.L., X.M., K.J.M., A.H., D.R., E.P., C.K., M.K.).
Kieren J MatherFrom McMaster University, York University, and Wharton Weight Management Clinic - all in Toronto (S.W.); Texas Diabetes and Endocrinology, Austin (T.B.), and Velocity Clinical Research at Medical City, Dallas (J.R.) - both in Texas; Alliance for Multispecialty Research, Norman, OK (L.C.); and Eli Lilly, Indianapolis (S.R., R.L., X.M., K.J.M., A.H., D.R., E.P., C.K., M.K.).ORCID 0000-0001-8696-7500
Axel HauptFrom McMaster University, York University, and Wharton Weight Management Clinic - all in Toronto (S.W.); Texas Diabetes and Endocrinology, Austin (T.B.), and Velocity Clinical Research at Medical City, Dallas (J.R.) - both in Texas; Alliance for Multispecialty Research, Norman, OK (L.C.); and Eli Lilly, Indianapolis (S.R., R.L., X.M., K.J.M., A.H., D.R., E.P., C.K., M.K.).
Deborah RobinsFrom McMaster University, York University, and Wharton Weight Management Clinic - all in Toronto (S.W.); Texas Diabetes and Endocrinology, Austin (T.B.), and Velocity Clinical Research at Medical City, Dallas (J.R.) - both in Texas; Alliance for Multispecialty Research, Norman, OK (L.C.); and Eli Lilly, Indianapolis (S.R., R.L., X.M., K.J.M., A.H., D.R., E.P., C.K., M.K.).
Edward PrattFrom McMaster University, York University, and Wharton Weight Management Clinic - all in Toronto (S.W.); Texas Diabetes and Endocrinology, Austin (T.B.), and Velocity Clinical Research at Medical City, Dallas (J.R.) - both in Texas; Alliance for Multispecialty Research, Norman, OK (L.C.); and Eli Lilly, Indianapolis (S.R., R.L., X.M., K.J.M., A.H., D.R., E.P., C.K., M.K.).
Christof KazdaFrom McMaster University, York University, and Wharton Weight Management Clinic - all in Toronto (S.W.); Texas Diabetes and Endocrinology, Austin (T.B.), and Velocity Clinical Research at Medical City, Dallas (J.R.) - both in Texas; Alliance for Multispecialty Research, Norman, OK (L.C.); and Eli Lilly, Indianapolis (S.R., R.L., X.M., K.J.M., A.H., D.R., E.P., C.K., M.K.).
Manige KonigFrom McMaster University, York University, and Wharton Weight Management Clinic - all in Toronto (S.W.); Texas Diabetes and Endocrinology, Austin (T.B.), and Velocity Clinical Research at Medical City, Dallas (J.R.) - both in Texas; Alliance for Multispecialty Research, Norman, OK (L.C.); and Eli Lilly, Indianapolis (S.R., R.L., X.M., K.J.M., A.H., D.R., E.P., C.K., M.K.).
GZGI Investigators
Eli Lilly (United States) · USAlliance for Multispecialty Research (United States) · USTexas Diabetes & Endocrinology · USVelocity Clinical Research (United States) · USYork University · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundObesity is a major risk factor for many leading causes of illness and death worldwide. Data are needed regarding the efficacy and safety of the nonpeptide glucagon-like peptide-1 (GLP-1) receptor agonist orforglipron as a once-daily oral therapy for weight reduction in adults with obesity.

methodsIn this phase 2, randomized, double-blind trial, we enrolled adults with obesity, or with overweight plus at least one weight-related coexisting condition, and without diabetes. Participants were randomly assigned to receive orforglipron at one of four doses (12, 24, 36, or 45 mg) or placebo once daily for 36 weeks. The percentage change from baseline in body weight was assessed at week 26 (primary end point) and at week 36 (secondary end point).

resultsA total of 272 participants underwent randomization. At baseline, the mean body weight was 108.7 kg, and the mean body-mass index (the weight in kilograms divided by the square of the height in meters) was 37.9. At week 26, the mean change from baseline in body weight ranged from -8.6% to -12.6% across the orforglipron dose cohorts and was -2.0% in the placebo group. At week 36, the mean change ranged from -9.4% to -14.7% with orforglipron and was -2.3% with placebo. A weight reduction of at least 10% by week 36 occurred in 46 to 75% of the participants who received orforglipron, as compared with 9% who received placebo. The use of orforglipron led to improvement in all prespecified weight-related and cardiometabolic measures. The most common adverse events reported with orforglipron were gastrointestinal events, which were mild to moderate, occurred primarily during dose escalation, and led to discontinuation of orforglipron in 10 to 17% of participants across dose cohorts. The safety profile of orforglipron was consistent with that of the GLP-1 receptor agonist class.

conclusionsDaily oral orforglipron, a nonpeptide GLP-1 receptor agonist, was associated with weight reduction. Adverse events reported with orforglipron were similar to those with injectable GLP-1 receptor agonists. (Funded by Eli Lilly; GZGI ClinicalTrials.gov number, NCT05051579.).

Indexed as

Anti-Obesity AgentsGlucagon-Like Peptide-1 Receptor AgonistsObesityWeight LossAdministration, OralAdultDiabetes Mellitus, Type 2Double-Blind MethodGlucagon-Like PeptidesHumansHypoglycemic AgentsAnti-Obesity AgentsGlucagon-Like Peptide-1 Receptor AgonistsGlucagon-Like PeptidesHypoglycemic Agents

Identifiers

PMID37351564
OpenAlexW4381716537

What Socratic holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.