PMID- 33475251
OWN - NLM
STAT- MEDLINE
DCOM- 20211025
LR  - 20221207
IS  - 1758-8111 (Electronic)
IS  - 1758-8103 (Linking)
VI  - 11
IP  - 2
DP  - 2021 Apr
TI  - Efficacy and safety of glucagon-like peptide-1/glucagon receptor co-agonist 
      JNJ-64565111 in individuals with type 2 diabetes mellitus and obesity: A 
      randomized dose-ranging study.
PG  - e12433
LID - 10.1111/cob.12433 [doi]
AB  - Weight loss has been shown to improve metabolic parameters and cardiovascular 
      risk in people with type 2 diabetes mellitus (T2DM). This phase 2 study evaluated 
      the safety and efficacy of JNJ-64565111, a dual agonist of GLP-1 and glucagon 
      receptors, in individuals with T2DM and class II/III obesity. In this randomized, 
      double-blind study, participants with T2DM (HbA1c 6.5%-9.5%), body mass index of 
      35 to 50 kg/m(2) and stable weight were randomly assigned (1:1:1:1) to placebo or 
      JNJ-64565111 (5.0 mg, 7.4 mg or 10.0 mg). The primary endpoint was percent change 
      from baseline in body weight at week 12. Of 195 dosed participants, 144 (73.8%) 
      completed treatment. At week 12, placebo-subtracted body weight changes were 
      -4.6%, -5.9% and -7.2% with JNJ-64565111 5.0 mg, 7.4 mg and 10.0 mg, 
      respectively. All JNJ-64565111 doses were associated with no change in HbA1c and 
      slight numerical elevation of fasting insulin. Numerical increases in fasting 
      plasma glucose were observed with JNJ-64565111 5.0 mg and 7.4 mg. Incidence of 
      treatment-emergent adverse events, especially nausea and vomiting, was higher 
      with JNJ-64565111 vs placebo. Overall, JNJ-64565111 significantly reduced body 
      weight in a dose-dependent manner vs placebo but was associated with greater 
      incidence of treatment-emergent adverse events, no HbA1c reductions, and 
      increased fasting plasma glucose and fasting insulin.
CI  - (c) 2021 World Obesity Federation.
FAU - Di Prospero, Nicholas A
AU  - Di Prospero NA
AUID- ORCID: 0000-0001-8231-6241
AD  - Janssen Research & Development, LLC, Raritan, New Jersey, USA.
FAU - Yee, Jaqueline
AU  - Yee J
AD  - Janssen Research & Development, LLC, Raritan, New Jersey, USA.
FAU - Frustaci, Mary E
AU  - Frustaci ME
AD  - Janssen Research & Development, LLC, Spring House, Pennsylvania, USA.
FAU - Samtani, Mahesh N
AU  - Samtani MN
AD  - Janssen Research & Development, LLC, Raritan, New Jersey, USA.
FAU - Alba, Maria
AU  - Alba M
AD  - Janssen Research & Development, LLC, Raritan, New Jersey, USA.
FAU - Fleck, Penny
AU  - Fleck P
AUID- ORCID: 0000-0003-3597-975X
AD  - Janssen Research & Development, LLC, Raritan, New Jersey, USA.
LA  - eng
GR  - Janssen Research & Development, LLC/
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20210121
PL  - England
TA  - Clin Obes
JT  - Clinical obesity
JID - 101560587
RN  - 0 (Blood Glucose)
RN  - 0 (Glucagon-Like Peptide-1 Receptor)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Receptors, Glucagon)
RN  - 89750-14-1 (Glucagon-Like Peptide 1)
SB  - IM
MH  - Blood Glucose
MH  - *Diabetes Mellitus, Type 2/drug therapy
MH  - Double-Blind Method
MH  - Glucagon-Like Peptide 1
MH  - Glucagon-Like Peptide-1 Receptor
MH  - Glycated Hemoglobin
MH  - Humans
MH  - Hypoglycemic Agents/adverse effects
MH  - *Obesity/complications/drug therapy
MH  - Receptors, Glucagon
OTO - NOTNLM
OT  - GLP-1/glucagon receptor co-agonist
OT  - obesity
OT  - oxyntomodulin
OT  - randomized trials
OT  - type 2 diabetes mellitus
OT  - weight loss
EDAT- 2021/01/22 06:00
MHDA- 2021/10/26 06:00
CRDT- 2021/01/21 08:40
PHST- 2020/08/21 00:00 [received]
PHST- 2020/11/17 00:00 [revised]
PHST- 2020/11/29 00:00 [accepted]
PHST- 2021/01/22 06:00 [pubmed]
PHST- 2021/10/26 06:00 [medline]
PHST- 2021/01/21 08:40 [entrez]
AID - 10.1111/cob.12433 [doi]
PST - ppublish
SO  - Clin Obes. 2021 Apr;11(2):e12433. doi: 10.1111/cob.12433. Epub 2021 Jan 21.