EVALUATING THE EFFICACY AND SAFETY OF MET097, A FULLY- BIASED ULTRA LONG-ACTING GLP-1 RA IN PEOPLE WITH OVERWEIGHT OR OBESITY AND TYPE 2 DIABETES: A PHASE 3, MULTI-CENTER RANDOMIZED PLACEBO-CONTROLLED TRIAL (VESPER-5)

Conditions

Obesity

Brief summary

Percent change from baseline in body weight at Week 64

Detailed description

Change from baseline in body weight (kg) at Week 64, Change in HbA1c (%) from baseline at Week 64, Occurrence at Week 64 of: o CCI % of reduction from baseline body weight o CCI % of reduction from baseline body weight o CCI % of reduction from baseline body weight o CCI % of reduction from baseline body weight, Change from baseline at Week 64 in: o Fasting triglycerides (mg/dL) o Non-high-density lipoprotein cholesterol (non-HDL-C) (mg/dL), Change from baseline in SBP (mmHg) at Week 64, Change from baseline in Short Form 36 health survey (SF-36) physical function domain score at Week 64, Percent change from baseline in body weight at Week 84, Change from baseline in body weight (kg) at Week 84, Change in HbA1c (%) from baseline at Week 84

Related papers

No related papers found yet.

Interventions

DRUGMET097 Injection

DRUG5mg/mL

DRUGMET097 matching placebo

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Percent change from baseline in body weight at Week 64	—

Secondary

Measure	Time frame
Change from baseline in body weight (kg) at Week 64, Change in HbA1c (%) from baseline at Week 64, Occurrence at Week 64 of: o CCI % of reduction from baseline body weight o CCI % of reduction from baseline body weight o CCI % of reduction from baseline body weight o CCI % of reduction from baseline body weight, Change from baseline at Week 64 in: o Fasting triglycerides (mg/dL) o Non-high-density lipoprotein cholesterol (non-HDL-C) (mg/dL), Change from baseline in SBP (mmHg) at Week 64, Change from baseline in Short Form 36 health survey (SF-36) physical function domain score at Week 64, Percent change from baseline in body weight at Week 84, Change from baseline in body weight (kg) at Week 84, Change in HbA1c (%) from baseline at Week 84	—

Measure

Time frame

Change from baseline in body weight (kg) at Week 64, Change in HbA1c (%) from baseline at Week 64, Occurrence at Week 64 of: o CCI % of reduction from baseline body weight o CCI % of reduction from baseline body weight o CCI % of reduction from baseline body weight o CCI % of reduction from baseline body weight, Change from baseline at Week 64 in: o Fasting triglycerides (mg/dL) o Non-high-density lipoprotein cholesterol (non-HDL-C) (mg/dL), Change from baseline in SBP (mmHg) at Week 64, Change from baseline in Short Form 36 health survey (SF-36) physical function domain score at Week 64, Percent change from baseline in body weight at Week 84, Change from baseline in body weight (kg) at Week 84, Change in HbA1c (%) from baseline at Week 84

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Outcome results

None listed