Phase II Clinical Study of HDM1005 Injection in Obese Adults Without Diabetes Mellitus

ConditionObesity
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorHangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

About this trial

It is a multicenter, randomized, double-blind, placebo-controlled phase II clinical trial to evaluate the efficacy and safety of HDM1005 injection in nondiabetic obese adults.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

Previous diagnosis of type 1, type 2, or any other type of diabetes.

History or family history of medullary thyroid carcinoma, C cell hyperplasia, or multiple endocrine neoplasia type 2.

According to the investigator's judgment, the subjects have endocrine diseases or histories that affect gastric emptying, may significantly affect body weight, or diseases or conditions that affect the absorption of gastrointestinal nutrients, such as Cushing syndrome, hypothyroidism or hyperthyroidism, bariatric surgery or other gastrectomy, irritable bowel syndrome, dyspepsia, and chronic pancreatitis; Or a history of acute pancreatitis or acute gallbladder disease within 3 months before signing ICF.

Unstable angina pectoris;

Trial design

Design model

Parallel

Treatments tested in this trial

  • HDM1005 injection or placebo

    Drug

    HDM1005 injection subcutaneous injection QW for 22weeks

Treatment groups

240 Participants
are divided into 5 treatment groups
Group A: HDM1005 dose cohort 1 QWExperimental treatment 1 intervention
Group B: HDM1005 dose cohort 2 QWExperimental treatment 1 intervention
Group C: HDM1005 dose cohort 3 QWExperimental treatment 1 intervention
Group D: HDM1005 dose cohort 4 QWExperimental treatment 1 intervention
Group E: placebo QWPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percentage Change From Baseline in Body Weight at Week 22

Weight was recorded in kilograms (kg), and accuracy to the nearest 0.1 kg

Time frame
Baseline, Week 22

Secondary outcomes

1

Percentage Change From Baseline in Body Weight at Week 4, Week 8, Week 12, Week 16

Weight was recorded in kilograms (kg), and accuracy to the nearest 0.1 kg

Time frame
Baseline, Week 4, Week 8, Week 12, Week 16
2

Percentage Change of Participants Achieving Weight Loss ≥ 5% and ≥ 10% at Week 22

Weight was recorded in kilograms (kg), and accuracy to the nearest 0.1 kg

Time frame
Baseline, Week 22
3

Change From Baseline in Body Mass Index (BMI)

BMI was recorded in kg/m2

Time frame
Baseline, Week 22
4

Change From Baseline in Waist Circumference

Waist Circumference was recorded in cm

Time frame
Baseline, Week 22

Other outcomes

Sponsors and contacts

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