Evidence mapPaperPMID 38807146Full record

Trial reportBMC medicine2024

Safety, tolerability, pharmacokinetics, and pharmacodynamics of TG103 injection in participants who are overweight or obese: a randomized, double-blind, placebo-controlled, multiple-dose phase 1b study.

Diaozhu Lin, Huisheng Xiao, Kexu Yang, Juan Li, Suiwen Ye, Yanqiong Liu, Shan Jing, Yang Lin, Yuanxun Yang, Lei Huang and 7 more

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase IMulticenter Study
In one paragraph

Trial report in BMC medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04855292 (A Randomized, Double-blind, Placebo-controlled, Multiple Dose Phase Ib Study in Overweight/Obese Subjects Without Diabetes to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Profile of TG103 Injection), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
field-weighted citation impact
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.

NCT04855292 phase1completednot on this map

A Randomized, Double-blind, Placebo-controlled, Multiple Dose Phase Ib Study in Overweight/Obese Subjects Without Diabetes to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Profile of TG103 Injection

TypeinterventionalSponsorCSPC Baike (Shandong) Biopharmaceutical Co., Ltd.Ran2021 to 2023Enrolled48ConditionsDiabetesArmsTG103 injection, Placebo
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Review
  2. Article
  3. Review
  4. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors.

Diaozhu Lin *Department of Endocrinology, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, China.
Huisheng Xiao *Department of Endocrinology, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, China.
Kexu Yang *Clinical Pharmacology Centre, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.
Juan Li *Phase I Clinical Trials Unit, Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School, Nanjing, China.
Suiwen YePhase I Clinical Trial Center, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, China.
Yanqiong LiuPhase I Clinical Trial Center, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, China.
Shan JingClinical Pharmacology Centre, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.
Yang LinClinical Pharmacology Centre, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.
Yuanxun YangPhase I Clinical Trials Unit, Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School, Nanjing, China.
Lei HuangPhase I Clinical Trials Unit, Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School, Nanjing, China.
Jing YuanCSPC Pharmaceutical Group Co., Ltd, Shijiazhuang, China.
Ziyan LiCSPC Pharmaceutical Group Co., Ltd, Shijiazhuang, China.
Jinlan YangCSPC Pharmaceutical Group Co., Ltd, Shijiazhuang, China.
Huanhuan GaoCSPC Pharmaceutical Group Co., Ltd, Shijiazhuang, China.
Ying XieCSPC Pharmaceutical Group Co., Ltd, Shijiazhuang, China.
Mingtong XuDepartment of Endocrinology, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, China. xuming@21cn.com.
Li YanDepartment of Endocrinology, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, China. yanli@mail.sysu.edu.cn.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTG103, a glucagon-like peptide-1 analog, is being investigated as an option for weight management. We aimed to determine the safety, tolerability, pharmacokinetics, and pharmacodynamics of TG103 injection in participants who are overweight or obese without diabetes.

methodsIn this randomized, double-blind, placebo-controlled, multiple-dose phase 1b study, participants aged 18-75 years with a body-mass index (BMI) ≥ 26.0 kg/m

resultsA total of 147 participants were screened, and 48 participants were randomly assigned to TG103 (15.0, 22.5 and 30.0 mg groups, n = 12 per group) or placebo (n = 12). The mean (standard deviation, SD) age of the participants was 33.9 (10.0) years; the mean bodyweight was 81.65 (10.50) kg, and the mean BMI was 29.8 (2.5) kg/m

conclusionsIn this trial, all three doses of once-weekly TG103 were well tolerated with an acceptable safety profile. TG103 demonstrated preliminary 12-week body weight loss without lifestyle interventions, thus showing great potential for the treatment of overweight and obesity.

trial registrationClinicalTrials.gov, NCT04855292. Registered on April 22, 2021.

Indexed as

ObesityOverweightAdolescentAdultAgedChinaDouble-Blind MethodFemaleGlucagon-Like Peptide 1HumansInjections, SubcutaneousMaleMiddle AgedPlacebosYoung AdultGlucagon-Like Peptide 1PlacebosObeseOverweightPharmacodynamicsPharmacokineticsSafetyTG103

Identifiers

PMID38807146
PMCPMC11134614

What Socratic holds

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LicenceCC BY
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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.